147 results on '"SCHUTT AJ"'
Search Results
2. PALA versus streptozotocin, doxorubicin, and MeCCNU in the treatment of patients with advanced pancreatic carcinoma
- Author
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Witte, RS, Ryan, LM, Schutt, AJ, Carbone, PP, Engstrom, PF, Witte, RS, Ryan, LM, Schutt, AJ, Carbone, PP, and Engstrom, PF
- Abstract
Seventy-three eligible, chemotherapy-naive, ambulatory patients with advanced pancreatic carcinoma were allocated to one of two treatment regimens: 35 received PALA (1250 mg/m2 daily x 5 every 4 weeks) and 38 were given SAM (streptozotocin 400 mg/m2 IV daily x 5, doxorubicin 45 mg/m2 IV on day 1 and 22, and methyl CCNU 60 mg/m2 orally on days 1 and 22 every 6 weeks). Doses were modified for myelo-, gi-, or cardiotoxicity. Adequate organ, bone marrow and cardiac function; a measurable lesion; adequate caloric intake; and a life expectancy of 2 months were required for treatment on this trial. One patient on each regimen had a partial response for response rates of 3% (95% confidence intervals, 0.08 to 17%). Median survival on the PALA arm was 5 months and median time to treatment failure was 2.6 months. SAM patients experienced median overall and progression free survivals of 3.4 and 1.9 months, respectively. The severe toxicity observed was almost exclusively myelosuppression on both regimens. One patient receiving SAM had lethal leukopenic sepsis during the first cycle as the only treatment-related death. Neither PALA nor SAM offer any therapeutic utility to patients with advanced pancreatic cancer.
- Published
- 1998
3. Advanced Colorectal Adenocarcinoma: Treatment With Amonafide
- Author
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Michael J. O'Connell, Robert F. Marschke, Patrick A. Burch, Schutt Aj, Joseph Rubin, John S. Kovach, and Harry S. Wieand
- Subjects
Cancer Research ,Text mining ,Oncology ,business.industry ,Cancer research ,Medicine ,Amonafide ,Colorectal adenocarcinoma ,business - Published
- 1994
4. Retinoic acid-binding protein in experimental and human colon tumors
- Author
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R. W. Brockman, Louis H. Weiland, Brahma P. Sani, Schutt Aj, and S M Condon
- Subjects
Cancer Research ,biology ,Binding protein ,Serum albumin ,Retinoic acid ,Rectum ,Ligand (biochemistry) ,Molecular biology ,Cecum ,chemistry.chemical_compound ,medicine.anatomical_structure ,Oncology ,Affinity chromatography ,Biochemistry ,chemistry ,medicine ,biology.protein ,Retinoic acid binding - Abstract
Retinoic acid-binding protein is present in metastatic murine colon tumors as well as in Lewis lung tumors and in lungs and brains of mice bearing these tumors; however, this protein is below the limits of detection in weakly-metastatic carcinomas and in normal lung, colon, or brains. These observations are interesting since they concern the possibility of measuring the binding protein levels of colon tumors in clinical specimens as biochemical markers in human malignancy. A total of thirty-three human colon tumors and related materials were analyzed for the presence of the binding protein. The interfering serum albumin, which nonspecifically binds retinoic acid, was eliminated by affinity chromatography. Of the twenty colon, cecum, and rectum tumors analyzed, 80% contained the binding protein in detectable amounts, and 20% showed nondetectable or marginally detectable amounts. Twenty-two percent of the human colon segments isolated from patients suspected for colon tumors contained the binding protein in readily detectable amounts, whereas 78% revealed nondetectable to marginally detectable amounts. The retinoic acid-binding protein of human colon tumor shared the same ligand specificity, thiol functions in ligand-binding, and sedimentation coefficient as the binding protein isolated from chick embryo skin. However, the human protein exhibited altered isoelectric pH.
- Published
- 1980
5. Usefulness of serial serum carcinoembryonic antigen (CEA) determinations during anticancer therapy or long-term followup of gastrointestinal carcinoma
- Author
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Vay Liang W. Go, Schutt Aj, M Ravry, and Charles G. Moertel
- Subjects
Cancer Research ,Chemotherapy ,medicine.medical_specialty ,endocrine system diseases ,biology ,business.industry ,Colorectal cancer ,medicine.medical_treatment ,Context (language use) ,medicine.disease ,Gastroenterology ,digestive system diseases ,Surgery ,Carcinoembryonic antigen ,Oncology ,Long term followup ,Internal medicine ,medicine ,biology.protein ,Gastrointestinal carcinoma ,Gastrointestinal cancer ,Day to day ,business ,neoplasms - Abstract
Repeated determinations of serum CEA levels in untreated advanced gastrointestinal cancer patients with initially elevated values showed day to day variations of ±35%. If there was no intervening chemotherapy, all such patients who were followed over long term showed progressively increasing CEA levels. With chemotherapy there was a general correlation between changes in serum CEA levels and clinically measured changes in tumor mass. Among patients who showed objective improvement, 75% had reduction in serum CEA levels (> 35%) and 87% had either reduced or unchanged levels. Among those who showed objective progression, 65% had increases in serum CEA levels (> 35%) and 80% had either increased or unchanged levels. Paradoxical reductions in CEA levels were observed in some patients approaching terminal status. Among 80 patients being followed with serial CEA determinations after potentially curative resections of large bowel cancer and normal postoperative CEA levels, 6 have again showed clinical evidence of malignant disease and in 5 of these there was concurrent elevation of serum CEA. Serial serum CEA determinations appear to have some value for following the course of gastrointestinal cancer patients after surgery or chemotherapy, but these determinations must be interpreted in the context of the over-all clinical picture.
- Published
- 1974
6. A Prospective, Randomized Controlled Trial of Megestrol Acetate Among High-Risk Patients with Resected Malignant Melanoma
- Author
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Daniel J. Schaid, Edward T. Creagan, James N. Ingle, and Schutt Aj
- Subjects
Male ,Oncology ,Cancer Research ,medicine.medical_specialty ,Time Factors ,Randomization ,Weight Gain ,law.invention ,Random Allocation ,chemistry.chemical_compound ,Randomized controlled trial ,Risk Factors ,law ,Internal medicine ,Adjuvant therapy ,Humans ,Medicine ,Prospective Studies ,Melanoma ,business.industry ,Megestrol Acetate ,Megestrol ,Middle Aged ,Prognosis ,medicine.disease ,Surgery ,Log-rank test ,chemistry ,Megestrol acetate ,Hormonal therapy ,Female ,Neoplasm Recurrence, Local ,business ,Follow-Up Studies ,medicine.drug - Abstract
In light of some evidence that hormonal factors may impact on malignant melanoma, we performed a randomized trial of megestrol acetate versus observation among 67 patients with high-risk resected stage I or stage II (nodal) malignant melanoma. Following stratification by relevant prognostic factors, we observed a statistical significance in survival advantage for megestrol acetate that approached 7.6 versus 2.6 years, median survival; two-sided log rank p = 0.06. Disease-free survival was also greater for patients who received this hormonal therapy (3.4 versus 1.1 years, median disease-free survival), but the difference was not statistically significant (two-sided log rank p = 0.20). The most noteworthy side effects were weight gain (median 6-month gain of 8.2 kg) and impotence. Fully recognizing the hazards of limited sample analyses and the need for confirmatory trials, our findings suggest a possible role for megestrol acetate as adjuvant therapy for selected patients with malignant melanoma.
- Published
- 1989
7. A phase I study of chlorozotocin (NSC 178248)
- Author
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Schutt Aj, John S. Kovach, James N. Ingle, Charles G. Moertel, Stephen Frytak, Michael J. O'Connell, and Joseph Rubin
- Subjects
Cancer Research ,Creatinine ,medicine.medical_specialty ,Leukopenia ,business.industry ,Nausea ,Large cell ,medicine.disease ,Gastroenterology ,chemistry.chemical_compound ,medicine.anatomical_structure ,Oncology ,chemistry ,Internal medicine ,Anesthesia ,Chlorozotocin ,medicine ,Vomiting ,Carcinoma ,Bone marrow ,medicine.symptom ,business - Abstract
Chlorozotocin was administered by rapid intravenous infusion to 35 patients with advanced cancer on either single-day of five-consecutive-day schedules. Total doses per course ranged from 12.5 to 200 mg/m2. On either administration schedule, dose limiting toxicities were thrombocytopenia and leukopenia at total doses of 150 mg/m2 to 200 mg/m2. Repetitive courses of drug may produce progressive impairment of renal and bone marrow function. Nausea and vomiting were infrequent and mild without definite relationship to dose. Minor reversible nondose related increases in SGOT and in serum creatinine occurred at all doses on both schedules. The plasma half-life of intact N-nitroso groups averaged 9.5 minutes after rapid intravenous administration of doses up to 40 mg/m2 and 12.5 minutes after doses of 150 or 200 mg/m2. No differences between plasma half-lives were seen between identical doses given on the first and fifth days of the five-day schedule. Objective tumor regression was noted in one patient with bronchogenic large cell carcinoma and one patient with metastatic melanoma.
- Published
- 1979
8. Therapy of locally unresectable pancreatic carcinoma: A randomized comparison of high dose (6000 rads) radiation alone, moderate dose radiation (4000 rads + 5-fluorouracil), and high dose radiation + 5-fluorouracil. The gastrointestinal tumor study group
- Author
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Howard M. Spiro, Richard J. Reitemeier, Louis H. Weiland, Schutt Aj, Jamie S. Barkin, Martin H. Kalser, Joseph M. Corson, Margaret A. Holbrook, Donald S. Childs, Jacob J. Lokich, Kenneth P. Ramming, H. O. Douglas, Joel W. Novak, Philip T. Lavin, Norman Zamcheck, Joseph Rubin, Richard G. Hahn, H. Nave, R. Mann-Kaplan, Joseph R. Bateman, Michael J. O'Connell, Patrick R. M. Thomas, Arthur H. Knowlton, Charles G. Moertel, Stephen Frytak, J. R. V. Brooks, Elliot M. Livstone, Howard E. Lessner, and J. Chaffey
- Subjects
Male ,Cancer Research ,Prognostic variable ,Time Factors ,Vomiting ,Unresectable Pancreatic Carcinoma ,medicine.medical_treatment ,Adenocarcinoma ,Carcinoembryonic antigen ,medicine ,Humans ,Probability ,Leukopenia ,Radiotherapy ,Performance status ,biology ,business.industry ,Anemia ,Nausea ,Radiotherapy Dosage ,Middle Aged ,medicine.disease ,Carcinoembryonic Antigen ,Pancreatic Neoplasms ,Radiation therapy ,Oncology ,Fluorouracil ,biology.protein ,Female ,medicine.symptom ,Nuclear medicine ,business ,medicine.drug - Abstract
One-hundred-ninety-four eligible and evaluable patients with histologically confirmed locally unresectable adenocarcinoma of the pancreas were randomly assigned to therapy with high-dose (6000 rads) radiation therapy alone, to moderate-dose (4000 rads) radiation + 5-fluorouracil (5-FU), and to high-dose radiation plus 5-FU. Median survival with radiation alone was only 51/2 months from date of diagnosis. Both 5-FU-containing treatment regimens produced a highly significant survival improvement when compared with radiation alone. Forty percent of patients treated with the combined regimens were still living at one year compared with 10% of patients treated with radiation only. Survival differences between 4000 rads plus 5-FU and 6000 rads plus 5-FU were not significant with an overall median survival of ten months. Significant prognostic variables, in addition to treatment, were pretreatment performance status and pretreatment CEA level.
- Published
- 1981
9. Brief Communication: Therapy of Advanced Colorectal Cancer With a Combination of 5-Flourouracil, Methyl-l,3-cis(2-chlorethyl)-1-nitrosourea, and Vincristine2
- Author
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Schutt Aj, Reitemeier Rj, Charles G. Moertel, and Richard G. Hahn
- Subjects
Oncology ,Cancer Research ,Nitrosourea ,Vincristine ,medicine.medical_specialty ,Nitrosourea Compound ,business.industry ,Colorectal cancer ,Semustine ,medicine.disease ,Advanced colorectal cancer ,chemistry.chemical_compound ,chemistry ,Fluorouracil ,Internal medicine ,Toxicity ,medicine ,business ,medicine.drug - Abstract
In a randomized, controlled study of 80 patients with advanced colorectal carcinoma, the combination of 5-fluorouracil (5-FU), methyl-1, 3-cis(2-chlorethyl)-1-nitrosourea, and vincristine produced an overall degree to toxicity comparable to that of 5-FU used alone. At 10 weeks, a positive objective response rate of 43.5% was observed with the three-drug combination compared to 19.5% with 5-FU alone (P less than 0.5).
- Published
- 1975
10. Corticosteroid therapy of preterminal gastrointestinal cancer
- Author
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Richard G. Hahn, Richard J. Reitemeier, Charles G. Moertel, and Schutt Aj
- Subjects
Cancer Research ,medicine.medical_specialty ,Palliative care ,business.industry ,media_common.quotation_subject ,Cancer ,Appetite ,medicine.disease ,Placebo ,Gastroenterology ,Oncology ,Internal medicine ,medicine ,Adenocarcinoma ,Gastrointestinal cancer ,medicine.symptom ,business ,Weight gain ,Dexamethasone ,media_common ,medicine.drug - Abstract
In a controlled double blind study involving 116 patients with far-advanced gastrointestinal cancer, dexamethasone at dosages of 0.75 and 1.5 mg four times daily produced improved appetite and sense of well-being in comparison to placebo treatment. This symptomatic palliation, however, was not accompanied by weight gain or improved performance status. Survival of the steroid treated patients was essentially identical to that of the placebo treated patients. Cancer 33:1607–1609, 1974.
- Published
- 1974
11. Brief Communication: Carcinoembryonic Antigen and Alpha-Fetoprotein in the Diagnosis of Gastric and Colonic Cancer: A Comparative Clinical Evaluation2
- Author
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Vay Liang W. Go, M Ravry, Charles G. Moertel, Thomas A. Waldmann, K R McIntire, and Schutt Aj
- Subjects
Cancer Research ,Pathology ,medicine.medical_specialty ,biology ,business.industry ,Colorectal cancer ,Stomach ,Cancer ,medicine.disease ,Blood proteins ,digestive system diseases ,medicine.anatomical_structure ,Carcinoembryonic antigen ,Oncology ,Antigen ,medicine ,Carcinoma ,biology.protein ,Alpha-fetoprotein ,business ,neoplasms - Abstract
Serum carcinoembryonic antigen (CEA) and alpha fetoprotein (AFP) levels were simultaneously measured in 100 colorectal and 45 gastric cancer patients. Of the 100 colorectal cancer patients 27 had localized or regional tumors and 73 had distant metastases (53 with liver metastases). Serum CEA increased ( .05) when patients who had distant spread with and without liver metastases were compared. 8/45 gastric carcinoma cases had localized or regional cancer and the other 36 had distant metastases (20 liver). Serum CEA was increased in 10 (22%) and AFP in 12 (27%). Only 1 patient had a concurrent increase in CEA and AFP. In contrast when both CEA and AFP were used as combined diagnostic indicators levels of either antigen were increased in 21 (47%) of the 45 cases.
- Published
- 1974
12. Prognostic Factors for Survival in Hepatocellular Carcinoma
- Author
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Falkson, G, Cnaan, A, Schutt, AJ, Ryan, LM, and Falkson, HC
- Subjects
Adult ,Male ,Carcinoma, Hepatocellular ,Liver Neoplasms ,Humans ,Female ,Oncology & Carcinogenesis ,Middle Aged ,Prognosis ,Aged - Abstract
Associations between patient characteristics and survival were investigated in 432 patients with hepatocellular carcinoma. Those patients were prospectively studied by the Eastern Cooperative Oncology Group, and each had his or her diagnosis reconfirmed by a pathology review panel. There were 301 North American and 131 South African patients. Sixty-nine % of the North American patients and 82% of the South African patients were male. There were 187 Black patients, 62 of whom were from North America. The study population is unique among hepatocellular carcinoma patients in that eligibility, evaluability, and endpoint definitions were standardized, and patients from both North America and South Africa received similar treatments at a similar time. Factors with the most significant adverse effect on survival are impaired performance status, male sex, older age, and disease symptoms (jaundice and reduced appetite). There is no apparent difference in survival between White and Black patients within North America, but North American patients survived longer than South African patients. Among the different therapies, p.o. 5-fluorouracil was associated with the poorest median survival time (6 wk), and i.v. 5-fluorouracil plus semustine with the best median survival time (24 wk). © 1988, American Association for Cancer Research. All rights reserved.
- Published
- 1988
13. A phase II study of the combination, 1,3-bis(2-chloroethyl)-1-nitrosourea (BCNU) and N-(phosphonacetyl)-L-aspartate (PALA), in patients with advanced large bowel cancer
- Author
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Schutt Aj, Charles G. Moertel, Michael J. O'Connell, Joseph Rubin, and Gertz Ma
- Subjects
Adult ,Male ,Phosphonoacetic Acid ,Cancer Research ,Nitrosourea ,medicine.medical_specialty ,Colorectal cancer ,medicine.medical_treatment ,Phases of clinical research ,Adenocarcinoma ,Gastroenterology ,chemistry.chemical_compound ,Internal medicine ,N-Phosphonacetyl-L-aspartate ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,Tumor type ,In patient ,Neoplasm Metastasis ,Aged ,Chemotherapy ,Aspartic Acid ,business.industry ,Rectal Neoplasms ,Middle Aged ,medicine.disease ,Carmustine ,Oncology ,chemistry ,Colonic Neoplasms ,Drug Evaluation ,Female ,Previously treated ,business - Abstract
A phase II study of BCNU and PALA was undertaken in advanced large bowel carcinoma. Thirty patients with advanced metastatic colorectal carcinoma were treated with the combination BCNU (200 mg/m2) every 6 weeks, and PALA (5.0 g/m2) every 3 weeks. Fifteen patients had received no prior chemotherapy and 15 had been previously treated with one or more cytotoxic agents. Only one patient met the criteria for a partial response, and this response was of only 3 months' duration. It would seem unlikely that the combination of BCNU and PALA holds the potential of response greater than BCNU alone and that further trials of this treatment regimen for this tumor type seem unwarranted.
- Published
- 1984
14. A phase II study of 6-diazo-5-oxo-L-norleucine (DON, NSC-7365) in advanced large bowel carcinoma
- Author
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Michael J. O'Connell, van Hazel Ga, Sorensen S, Joseph Rubin, Schutt Aj, and Charles G. Moertel
- Subjects
Adult ,Male ,Cancer Research ,medicine.medical_specialty ,Nausea ,Vomiting ,Diazooxonorleucine ,Phases of clinical research ,Large Bowel Carcinoma ,Adenocarcinoma ,Gastroenterology ,chemistry.chemical_compound ,Internal medicine ,medicine ,Humans ,Aged ,business.industry ,Rectal Neoplasms ,Middle Aged ,medicine.disease ,6-Diazo-5-oxo-L-norleucine ,Oncology ,chemistry ,Colonic Neoplasms ,Drug Evaluation ,Female ,medicine.symptom ,business ,Azo Compounds - Published
- 1983
15. A randomized clinical trial of combination chemotherapy in advanced colorectal cancer
- Author
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Michael J. O'Connell, Joseph Rubin, Charles G. Moertel, M Scott, Richard G. Hahn, and Schutt Aj
- Subjects
Adult ,Male ,Cancer Research ,medicine.medical_specialty ,Vincristine ,Time Factors ,Colorectal cancer ,medicine.medical_treatment ,Gastroenterology ,law.invention ,Random Allocation ,Randomized controlled trial ,law ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,Prospective Studies ,Aged ,Chemotherapy ,Clinical Trials as Topic ,Performance status ,business.industry ,Rectal Neoplasms ,Triazines ,Combination chemotherapy ,Middle Aged ,medicine.disease ,Surgery ,Semustine ,Clinical trial ,Oncology ,Colonic Neoplasms ,Female ,Liver function ,Fluorouracil ,business ,Razoxane ,medicine.drug - Abstract
One hundred and sixty-five patients with advanced colorectal cancer were entered into a prospectively randomized trial of combination chemotherapy comparing three 5-fluorouracil plus methyl CCNU (FM)-based regimens: FM plus ICRF-159 (FMI), FM plus triazinate (FMT), and FM plus vincristine (FMV). Patients were stratified according to performance status, anatomic site of primary indicator lesion, and prior chemotherapy. Those with abnormal kidney or liver function were randomized between FMI and FMV because triazinate depends on both hepatic and renal mechanisms for elimination. There were no significant differences between the treatment regimens in objective response rate (11%-17%), interval to progression (median, 10-14 weeks), or survival (median, 5-6 months). The primary side effect observed was hematologic toxicity, which tended to increase in severity with repeated courses of therapy. Although ICRF-159 and triazinate have been shown to have limited single-agent phase II activity against colorectal cancer in previous trials, neither agent combined with 5-fluorouracil plus methyl CCNU has an improved treatment effect compared with FMV. We do not recommend the further use of these regimens in the treatment of advanced colorectal cancer.
- Published
- 1987
16. A phase II study of alanosine in advanced large bowel carcinoma
- Author
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Charles G. Moertel, Hineman, Richard G. Hahn, Joseph Rubin, and Schutt Aj
- Subjects
Adult ,Male ,Cancer Research ,medicine.medical_specialty ,medicine.medical_treatment ,Phases of clinical research ,Large Bowel Carcinoma ,Adenocarcinoma ,Gastroenterology ,chemistry.chemical_compound ,Text mining ,Internal medicine ,Medicine ,Humans ,Colorectal adenocarcinoma ,Stomatitis ,Aged ,Chemotherapy ,Alanine ,Antibiotics, Antineoplastic ,business.industry ,Rectal Neoplasms ,Nausea ,Middle Aged ,medicine.disease ,Alanosine ,Oncology ,chemistry ,Toxicity ,Colonic Neoplasms ,Drug Evaluation ,Female ,business - Abstract
Thirty patients with advanced metastatic colorectal adenocarcinoma were treated with alanosine at a dose of 160 mg/m2 daily for 5 days every 4 weeks. Sixteen patients had received no prior chemotherapy and 14 had been previously treated with one or more cytotoxic agents. No patient met the criteria for a complete or partial response. The major toxicity was stomatitis.
- Published
- 1983
17. A phase II study of chlorozotocin in advanced large bowel carcinoma. A cooperative study between two institutions
- Author
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Philip S. Schein, Joseph Rubin, Schutt Aj, Charles G. Moertel, Hoth D, and Michael J. O'Connell
- Subjects
Adult ,Male ,Cancer Research ,medicine.medical_specialty ,Time Factors ,Colorectal cancer ,Nausea ,Vomiting ,Phases of clinical research ,Antineoplastic Agents ,Large Bowel Carcinoma ,Adenocarcinoma ,Gastroenterology ,Streptozocin ,chemistry.chemical_compound ,Internal medicine ,Chlorozotocin ,medicine ,Humans ,Aged ,business.industry ,Rectal Neoplasms ,Anemia ,Leukopenia ,Middle Aged ,medicine.disease ,Thrombocytopenia ,Regimen ,Oncology ,chemistry ,Toxicity ,Colonic Neoplasms ,Drug Evaluation ,Female ,medicine.symptom ,business - Abstract
Mayo clinic and georgetown university carried out a cooperative phase II study of chlorozotocin in measurable advanced large bowel carcinoma. Of 78 evaluable patients randomized, 39 received low-dose (120 mg/m2 if previously untreated, 100 mg/m2 if previously treated) and 39 high-dose (200 mg/m2 if previously untreated, 175 mg/m2 if previously treated) chlorozotocin intravenously at 6-week intervals. Both groups were comparable in regard to age, prior treatment, treating institution, site of metastases, and performance scores. Overall response rate was 8%, including 5% in low-dose patients and 10% in high-dose patients. Toxicity was mild to moderate, with gastrointestinal toxicity substantially, and hematologic toxicity somewhat less, than seen with other nitrosoureas. Time to progression and survival showed no significant difference between patients treated on the low- and high-dose schedules. As chlorozotocin produced less nausea and vomiting than other nitrosoureas, even in the high-dose regimen, it should be considered for evaluation in neoplasms where nitrosoureas have shown more activity than in colorectal carcinoma.
- Published
- 1984
18. A random phase II study of mitoxantrone and cisplatin in patients with hepatocellular carcinoma: An ECOG study
- Author
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Falkson, G, Ryan, LM, Johnson, LA, Simson, IW, Coetzer, BJ, Carbone, PP, Creech, RH, Schutt, AJ, Falkson, G, Ryan, LM, Johnson, LA, Simson, IW, Coetzer, BJ, Carbone, PP, Creech, RH, and Schutt, AJ
- Abstract
Of 86 patients entered in an Eastern Cooperative Oncology Group (ECOG) random Phase II study of mitoxantrone (DHAD) and cisplatin (DDP) in primary liver cancer, 69 were eligible. Nine of the 13 ineligible patients were excluded after a pathology review. Sixty‐one percent of the patients were North American, and 39% were South African. The most common severe or the worst toxicity on DHAD was hematologic; and to DDP, hematologic and vomiting. Of the 69 eligible patients, 21 experienced severe, life‐threatening or fatal toxic reactions. Two patients treated with DDP had partial responses. With a 95% confidence interval, the true response rate to DHAD was less than 8%, and to DDP, less than 17%. The median survival time was 14 weeks on both drugs. Assuming a proportional hazards model, factors that are significantly associated with survival are patient performance status, the presence of the symptoms, raised bilirubin and hepatomegaly, and clinical evidence of cirrhosis. Any differences between survival rates for South African and North American patients were largely explainable by these factors. Copyright © 1987 American Cancer Society
- Published
- 1987
19. Comparison of 5-fluorouracil alone, 5-fluorouracil with levamisole, and 5-fluorouracil with hepatic irradiation in the treatment of patients with residual, nonmeasurable, intra-abdominal metastasis after undergoing resection for colorectal carcinoma.
- Author
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Witte RS, Cnaan A, Mansour EG, Barylak E, Harris JE, and Schutt AJ
- Subjects
- Adjuvants, Immunologic administration & dosage, Adult, Aged, Aged, 80 and over, Colorectal Neoplasms surgery, Combined Modality Therapy, Female, Fluorouracil administration & dosage, Humans, Levamisole administration & dosage, Liver Neoplasms radiotherapy, Male, Middle Aged, Neoplasm Recurrence, Local, Neoplasm, Residual, Survival Analysis, Treatment Outcome, Abdominal Neoplasms drug therapy, Abdominal Neoplasms secondary, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma drug therapy, Carcinoma secondary, Colorectal Neoplasms pathology, Liver Neoplasms drug therapy, Liver Neoplasms secondary
- Abstract
Background: The authors conducted a randomized Phase III trial of three treatment regimens for patients with residual, nonmeasurable, intra-abdominal metastatic disease after undergoing resection for primary colorectal carcinoma., Methods: To be eligible for this study, patients had to be both free of other malignancies and capable of starting their therapy within 3-6 weeks after surgery. They were required to have an Eastern Cooperative Oncology Group performance status < 3; to be chemotherapy, radiation, and immunotherapy naïve; to have adequate bone marrow, renal, and hepatic function; and to provide written, informed consent. The patients were divided into two cohorts: patients with no demonstrable hepatic metastasis (Group A) and patients with hepatic metastasis (Group B)., Results: The 229 patients in Group A were randomized to receive either 5-fluorouracil (5-FU) (n = 116 patients) or 5-FU with levamisole (n = 113 patients). The median survival (15.4 months and 15.3 months, respectively, for Groups A and B) was virtually identical. The two groups also were similar in terms of time to treatment progression, which was 7.9 months for group that received 5-FU alone 7.7 months for the group that received levamisole with 5-FU. The 168 patients in Group B with hepatic metastasis underwent a three-way randomization: 5-FU alone (n = 60 patients), 5-FU with levamisole (n = 54 patients), and 5-FU with hepatic irradiation (n = 54 patients). The median overall survival for the three treatment arms were similar, with 17.3 months for the group that received 5-FU alone, 16 months for the group that received 5-FU with levamisole, and 14.4 months for the group that received hepatic irradiation in addition to 5-FU: The time to treatment failure was 6.7 months, 6.8 months, and 8.3 months, respectively, for the three groups. The toxicity experienced by patients was as expected with the regimens, and no differences were observed between any of the treatment groups. The primary toxicities were hematologic and gastrointestinal. There was one treatment-related death due to adult respiratory distress syndrome, which occurred on the first day of the fourth cycle of 5-FU and levamisole. Other Grade 4 toxicities included nine patients with Grade 4 leukopenia, one patient with Grade 4 sepsis, and one patient with Grade 4 gastrointestinal toxicity, including blood loss and diarrhea., Conclusions: This study showed no treatment advantage for any of the combined modalities over 5-FU alone in this group of patients with intra-abdominal, nonmeasurable disease., (Copyright 2001 American Cancer Society.)
- Published
- 2001
20. Combined chemoradiotherapy vs. radiotherapy alone for early stage squamous cell carcinoma of the esophagus: a study of the Eastern Cooperative Oncology Group.
- Author
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Smith TJ, Ryan LM, Douglass HO Jr, Haller DG, Dayal Y, Kirkwood J, Tormey DC, Schutt AJ, Hinson J, and Sischy B
- Subjects
- Analysis of Variance, Carcinoma, Squamous Cell pathology, Carcinoma, Squamous Cell surgery, Combined Modality Therapy, Disease-Free Survival, Elective Surgical Procedures, Esophageal Neoplasms pathology, Esophageal Neoplasms surgery, Female, Fluorouracil administration & dosage, Humans, Male, Mitomycin administration & dosage, Neoplasm Recurrence, Local mortality, Neoplasm Staging, Quality Control, Radiation Injuries pathology, Radiation-Sensitizing Agents therapeutic use, Radiotherapy Dosage, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Squamous Cell drug therapy, Carcinoma, Squamous Cell radiotherapy, Esophageal Neoplasms drug therapy, Esophageal Neoplasms radiotherapy
- Abstract
Squamous carcinoma of the thoracic esophagus has an extremely poor prognosis. This study, EST-1282, was undertaken by the Eastern Cooperative Oncology Group (ECOG) to determine whether the combined use of 5-fluorouracil (5-FU), mitomycin C, and radiation therapy improved the disease-free survival and overall survival of patients with carcinoma of the esophagus, compared to those who received radiation therapy alone. Two- and 5-year survivals were 12% and 7% in the radiation alone arm and 27% and 9% in the chemoradiation arm. Patients treated with chemoradiation had a longer median survival (14.8 months), compared to patients receiving radiation therapy alone (9.2 months). This difference was statistically significant. The same pattern of survival was noted in almost all subgroups independent of whether surgical resection was performed.
- Published
- 1998
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21. PALA versus streptozotocin, doxorubicin, and MeCCNU in the treatment of patients with advanced pancreatic carcinoma.
- Author
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Witte RS, Ryan LM, Schutt AJ, Carbone PP, and Engstrom PF
- Subjects
- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols adverse effects, Aspartic Acid adverse effects, Aspartic Acid therapeutic use, Doxorubicin administration & dosage, Female, Humans, Male, Middle Aged, Pancreatic Neoplasms pathology, Phosphonoacetic Acid adverse effects, Phosphonoacetic Acid therapeutic use, Semustine administration & dosage, Streptozocin administration & dosage, Survival Analysis, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Aspartic Acid analogs & derivatives, Pancreatic Neoplasms drug therapy, Phosphonoacetic Acid analogs & derivatives
- Abstract
Seventy-three eligible, chemotherapy-naive, ambulatory patients with advanced pancreatic carcinoma were allocated to one of two treatment regimens: 35 received PALA (1250 mg/m2 daily x 5 every 4 weeks) and 38 were given SAM (streptozotocin 400 mg/m2 i.v. daily x 5, doxorubicin 45 mg/m2 i.v. on day 1 and 22, and methyl CCNU 60 mg/m2 orally on days 1 and 22 every 6 weeks). Doses were modified for myelo-, gi-, or cardiotoxicity. Adequate organ, bone marrow and cardiac function; a measurable lesion; adequate caloric intake; and a life expectancy of 2 months were required for treatment on this trial. One patient on each regimen had a partial response for response rates of 3% (95% confidence intervals, 0.08 to 17%). Median survival on the PALA arm was 5 months and median time to treatment failure was 2.6 months. SAM patients experienced median overall and progression free survivals of 3.4 and 1.9 months, respectively. The severe toxicity observed was almost exclusively myelosuppression on both regimens. One patient receiving SAM had lethal leukopenic sepsis during the first cycle as the only treatment-related death. Neither PALA nor SAM offer any therapeutic utility to patients with advanced pancreatic cancer.
- Published
- 1998
- Full Text
- View/download PDF
22. Phase II trials of 5-fluorouracil and leucovorin in patients with metastatic gastric or pancreatic carcinoma.
- Author
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Rubin J, Gallagher JG, Schroeder G, Schutt AJ, Dalton RJ, Kugler JW, Morton RF, Mailliard JA, and Burch PA
- Subjects
- Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols adverse effects, Cause of Death, Female, Fluorouracil administration & dosage, Fluorouracil adverse effects, Humans, Leucovorin administration & dosage, Leucovorin adverse effects, Male, Middle Aged, Pancreatic Neoplasms mortality, Stomach Neoplasms mortality, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Pancreatic Neoplasms drug therapy, Stomach Neoplasms drug therapy
- Abstract
Background: Previous trials in patients with colorectal carcinoma have indicated that enhancement of 5-fluorouracil (5-FU) by leucovorin (LV) can result in an improved response rate and increased survival., Methods: Phase II trials were performed with patients who had either gastric or papcreatic adenocarcinoma with inetastases. Forty-one gastric carcinoma patients and 31 pancreatic carcinoma patients with measurable disease were treated with 5-FU, 425 mg/m2 intraveneosly (i.v.) on Days 1-5 plus LV, 20 mg/m2 i.v., on Days 1-5, reported at 4 and 8 weeks, and then every 5 weeks thereafter., Results: The patients with metastatic gastric carcinoma had a median survival of 4.8 months. There was a 22% objective response rate, including a 4.9% complete response rate and a 17.1% partial response rate. Among the 31 patients with pancreatic carcinoma, there was a median survival of 5.7 months. No patients in this group showed a response., Conclusions: The response rate for patients with metastatic gastric adenocarcinoma was modest and this regimen may provide temporary palliation for some patients. However, 5-FU and LV treatment is ineffective against metastatic pancreatic carcinoma.
- Published
- 1996
- Full Text
- View/download PDF
23. A phase III evaluation of a somatostatin analogue (octreotide) in the treatment of patients with asymptomatic advanced colon carcinoma. North Central Cancer Treatment Group and the Mayo Clinic.
- Author
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Goldberg RM, Moertel CG, Wieand HS, Krook JE, Schutt AJ, Veeder MH, Mailliard JA, and Dalton RJ
- Subjects
- Aged, Antineoplastic Agents, Hormonal adverse effects, Double-Blind Method, Female, Humans, Male, Middle Aged, Octreotide adverse effects, Survival Analysis, Antineoplastic Agents, Hormonal therapeutic use, Carcinoma drug therapy, Colonic Neoplasms drug therapy, Octreotide therapeutic use
- Abstract
Background: The purpose of this study was to determine by randomized, controlled, double-blind evaluation whether therapy with the somatostatin analogue, octreotide, would delay tumor progression and improve survival of patients with metastatic colorectal carcinomas who were ambulatory with no significant symptoms., Methods: Two hundred sixty patients with an Eastern Cooperative Oncology Group performance status of 0 or 1 and without symptoms related to colon cancer were randomized to receive 150 micrograms of octreotide subcutaneously three times daily or, initially, no treatment. After 91 patients were entered in the double-blind study, saline placebo injections were used for patients in the control arm., Results: The randomization culminated in balanced assignment of patients with respect to disease site(s), presence or absence of measurable or evaluable disease, and interval from diagnosis of metastasis to protocol entry. Steatorrhea and diarrhea, usually mildly severe, resulted more often from treatment than from the placebo. The major end points were time to progression and survival. Curves for both parameters overlapped in the blind and open trial segments., Conclusion: Octreotide at a dose of 150 micrograms given three times daily is not effective therapy for patients with advanced asymptomatic colon carcinoma.
- Published
- 1995
- Full Text
- View/download PDF
24. Adjuvant therapy for colon cancer.
- Author
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Schutt AJ
- Subjects
- Chemotherapy, Adjuvant, Colonic Neoplasms drug therapy, Humans, Antineoplastic Agents therapeutic use, Colonic Neoplasms surgery
- Abstract
More tightly defined and controlled studies have found definite benefit associated with adjuvant therapy following surgery for stage III colon cancer. The decision for those with stage II disease is best made on an individual basis.
- Published
- 1995
25. Advanced colorectal adenocarcinoma: treatment with amonafide.
- Author
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Marschke RF Jr, Wieand HS, O'Connell MJ, Rubin J, Schutt AJ, Burch PA, and Kovach JS
- Subjects
- Adenine, Humans, Intercalating Agents, Naphthalimides, Organophosphonates, Antineoplastic Agents therapeutic use, Carcinoma drug therapy, Colorectal Neoplasms drug therapy, Imides therapeutic use, Isoquinolines therapeutic use
- Published
- 1994
- Full Text
- View/download PDF
26. Pseudomyxoma peritonei. Long-term patient survival with an aggressive regional approach.
- Author
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Gough DB, Donohue JH, Schutt AJ, Gonchoroff N, Goellner JR, Wilson TO, Naessens JM, O'Brien PC, and van Heerden JA
- Subjects
- Adolescent, Adult, Aged, Combined Modality Therapy, Female, Follow-Up Studies, Humans, Male, Middle Aged, Multivariate Analysis, Peritoneal Neoplasms mortality, Peritoneal Neoplasms pathology, Ploidies, Prognosis, Pseudomyxoma Peritonei mortality, Pseudomyxoma Peritonei pathology, Reoperation, Retrospective Studies, Survival Rate, Neoplasm Recurrence, Local epidemiology, Peritoneal Neoplasms surgery, Pseudomyxoma Peritonei surgery
- Abstract
Objective: The aims of this study were to analyze the natural history of patients with pseudomyxoma peritonei (PMP), evaluate clinical and pathologic variables as prognostic indicators, and review the authors' experience with different treatments., Summary Background Data: PMP is an unusual form of intra-abdominal neoplasm that presents with large amounts of extracellular mucin. Diffuse peritoneal spread occurs in most patients with PMP, and distant metastasis is infrequent. Debulking surgery, radiation therapy (radioisotope and external beam), and chemotherapy (both intraperitoneal and systemic) have all been advocated for optional patient management, but the variability of patients studied, the small patient numbers, and the prolonged course of this disease make the evaluation of results difficult., Methods: Fifty-six patients were treated for PMP at the Mayo Clinic between 1957 and 1983. The data were collected retrospectively. Univariate (log-rank test) and multivariate (Cox regression model) analyses were performed for disease recurrence and patient survival., Results: Most patients with PMP had carcinomas of the appendix (52%) or ovary (34%). All gross tumor could be removed only in the 34% of patients with limited disease. Although tumor progression occurred in 76% of patients, the 1-, 5-, and 10-year survival rates were 98%, 53%, and 32%, respectively. Adverse predictors of patient survival included weight loss (p = 0.001), abdominal distention (p = 0.004), use of systemic chemotherapy (p = 0.005), diffuse disease (p = 0.038), and invasion of other organs (p = 0.04). Intraperitoneal chemotherapy (p = 0.009) and radioisotopes (p = 0.0043) both were effective in prolonging the recurrence time of symptomatic PMP., Conclusions: Although PMP is an indolent disease, aggressive surgical debulking followed by intraperitoneal radioisotopes and/or chemotherapy should be considered because of the diffuse peritoneal involvement.
- Published
- 1994
- Full Text
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27. Prospective phase I evaluation of radiation therapy, 5-fluorouracil, and levamisole in locally advanced gastrointestinal cancer.
- Author
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Martenson JA Jr, Schutt AJ, Grado GL, Maples WJ, and Marschke RF Jr
- Subjects
- Combined Modality Therapy, Fluorouracil administration & dosage, Fluorouracil adverse effects, Humans, Levamisole administration & dosage, Levamisole adverse effects, Prospective Studies, Radiotherapy adverse effects, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Gastrointestinal Neoplasms therapy
- Abstract
Purpose: A recent clinical trial in patients with resected node-positive colon cancer demonstrated a clear survival advantage for patients treated with adjuvant 5-fluorouracil and levamisole. This finding led to interest in development of a Phase III trial comparing 5-fluorouracil and levamisole with 5-fluorouracil, levamisole, and radiation therapy in colon cancer patients at high risk for local recurrence. A prospective evaluation of 5-fluorouracil, levamisole, and radiation therapy was undertaken with the goal of establishing a satisfactorily tolerated regimen., Methods and Materials: Fifteen patients were studied who had locally advanced or locally recurrent upper abdominal gastrointestinal cancer (11 patients) or large bowel cancer confined to the pelvis (4 patients). The tumor and regional lymph nodes received 45 Gy in 25 fractions. Patients with pelvic tumors subsequently were treated with a radiation boost of 5.4-9 Gy in 3-5 fractions. Systemic therapy consisted of 5-fluorouracil, 450 mg/m2, given intravenously for 3 consecutive days during the first and last weeks of radiation therapy. Levamisole, 50 mg, given orally 3 times daily was used for 3 consecutive days concurrent with initiation of radiation therapy and 5-fluorouracil, at the beginning of the third week of radiation therapy, and concurrent with the final 3-day course of 5-fluorouracil., Results: Therapy was generally well tolerated. In two patients, > or = grade 3 nonhematologic toxicity developed and consisted of transient small bowel obstruction in one and severe nausea and vomiting related to levamisole administration in another. One patient experienced grade 3 hematologic toxicity with a leukocyte count nadir of 1,600 cells/microL., Conclusions: These results are similar to the toxicity profile reported elsewhere for radiation therapy and 5-fluorouracil. The addition of levamisole to radiation therapy and 5-fluorouracil does not appear to increase toxicity significantly.
- Published
- 1994
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28. Evaluation of external-beam radiation therapy plus 5-fluorouracil (5-FU) versus external-beam radiation therapy plus hycanthone (HYC) in confined, unresectable pancreatic cancer.
- Author
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Earle JD, Foley JF, Wieand HS, Kvols LK, McKenna PJ, Krook JE, Tschetter LK, Schutt AJ, and Twito DI
- Subjects
- Adenocarcinoma drug therapy, Adenocarcinoma radiotherapy, Adult, Aged, Aged, 80 and over, Combined Modality Therapy, Evaluation Studies as Topic, Female, Fluorouracil administration & dosage, Humans, Hycanthone administration & dosage, Infusions, Intravenous, Male, Middle Aged, Pancreatic Neoplasms drug therapy, Pancreatic Neoplasms radiotherapy, Prospective Studies, Survival Analysis, Survival Rate, Adenocarcinoma therapy, Fluorouracil therapeutic use, Hycanthone therapeutic use, Pancreatic Neoplasms therapy
- Abstract
From March 1981 to November 1987, 87 patients with histologically confirmed pancreatic adenocarcinoma, unresectable but confined to the pancreatic region, were randomized to two treatments. The standard treatment was 40-50 Gy external-beam radiation therapy (RT) to gross tumor plus potential microscopic tumor with a 5 Gy boost to gross tumor plus a 1.5-2.0 cm margin, using multiple fields and 5-fluorouracil (5-FU) 500 mg/m2/d intravenously by rapid infusion. The 5-FU was given each of the initial 3 days of each of three 20 Gy radiation courses. The experimental treatment used identical radiation fields, but the two Gy daily radiation fractions were administered in a continuous course to a total dose of 50 Gy. Hycanthone was administered 60 mg/m2 intravenously within 2 to 4 hr during each day of the 5-day course of infusions during the first and fifth weeks of radiation therapy. There was no statistically significant difference between treatment arms in survival (p = 0.82) or disease-free survival (p = 0.27). Seven percent of hycanthone-treated patients demonstrated hepatic toxicity which was usually mild in nature. There was, however, one death due to hepatic toxicity.
- Published
- 1994
- Full Text
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29. all-trans retinoic acid: a dose-seeking study in solid tumors.
- Author
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Pitot HC 4th, Rubin J, Kovach JS, Schutt AJ, and Adamson PC
- Subjects
- Administration, Oral, Adult, Aged, Dose-Response Relationship, Drug, Humans, Middle Aged, Tretinoin pharmacokinetics, Colorectal Neoplasms drug therapy, Neoplasms drug therapy, Tretinoin therapeutic use, Tretinoin toxicity
- Published
- 1993
- Full Text
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30. Phase II trial of VP-16, bleomycin, and cisplatin in patients with advanced nonsquamous cell head and neck neoplasms.
- Author
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Creagan ET, Schutt AJ, Richardson RL, and Schaid DJ
- Subjects
- Adult, Aged, Bleomycin administration & dosage, Cisplatin administration & dosage, Etoposide administration & dosage, Female, Humans, Male, Middle Aged, Remission Induction, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Head and Neck Neoplasms drug therapy
- Abstract
We observed a 45% response rate from the combination of VP-16, bleomycin, and cisplatin among 20 patients with nonsquamous cell head and neck cancer. The regressions were partial and typically occurred within 1 to 2 months of commencing treatment. The median response duration for responding patients was 3 months. Median survival of responders was 8 months, similar to that of all study participants. Gastrointestinal and hematologic sequelae were predictable and manageable. This regimen may provide some transient palliation for selected patients with these neoplasms, but no substantive impact on survival.
- Published
- 1993
31. Combined doxorubicin and alpha-interferon therapy of advanced hepatocellular carcinoma.
- Author
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Kardinal CG, Moertel CG, Wieand HS, Schutt AJ, O'Connell MJ, Wright K, Wiesenfeld M, Tschetter LK, and Krook JE
- Subjects
- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols adverse effects, Doxorubicin administration & dosage, Female, Humans, Interferon alpha-2, Interferon-alpha administration & dosage, Male, Middle Aged, Recombinant Proteins, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Hepatocellular drug therapy, Liver Neoplasms drug therapy
- Abstract
Background: Modest activity for doxorubicin has been detected repeatedly for the therapy of advanced hepatocellular carcinoma. Variable activity in this disease also has been documented for alpha-interferon. Preclinical data indicated the possibility that alpha-interferon could enhance or add to the cytotoxic effect of doxorubicin., Methods: The authors evaluated the use of alpha-interferon at a dose of 12 x 10(6) units/m2/day for 5 days given by intramuscular injection plus doxorubicin 25-40 mg/m2 given intravenously on day 3 (both repeated every 4 weeks) for the treatment of advanced hepatocellular carcinoma., Results: Among 31 eligible patients treated, there was only one instance of objective tumor regression. The median survival for all patients was 10 months. Both hematologic and nonhematologic toxicity were significant but tolerable to the patients., Conclusions: The 3% response rate indicated that, by the method used, the addition of alpha-interferon to doxorubicin does not improve the clinical effectiveness. This combination cannot be recommended for further study.
- Published
- 1993
- Full Text
- View/download PDF
32. Multifocal leukoencephalopathy: occurrence during 5-fluorouracil and levamisole therapy and resolution after discontinuation of chemotherapy.
- Author
-
Kimmel DW and Schutt AJ
- Subjects
- Adenocarcinoma drug therapy, Antineoplastic Combined Chemotherapy Protocols adverse effects, Colonic Neoplasms drug therapy, Humans, Male, Middle Aged, Fluorouracil adverse effects, Leukoencephalopathy, Progressive Multifocal chemically induced, Levamisole adverse effects
- Abstract
We report the fourth case of cerebral demyelinating disease associated with 5-fluorouracil and levamisole hydrochloride therapy for adenocarcinoma of the colon. The initial manifestations included subacute progressive decline in mental status, ataxia, dysarthria, and diplopia. Magnetic resonance imaging of the head demonstrated multifocal enhanced lesions in the white matter. The patient experienced improvement, without corticosteroid treatment, from 2 weeks to 4 months after cessation of chemotherapy.
- Published
- 1993
- Full Text
- View/download PDF
33. A phase II study of intravenous 6-thioguanine (NSC-752) in advanced colorectal carcinoma.
- Author
-
Rubin J, Schutt AJ, and Pitot HC 4th
- Subjects
- Adult, Aged, Colorectal Neoplasms secondary, Drug Evaluation, Female, Humans, Injections, Intravenous, Male, Middle Aged, Remission Induction, Thioguanine administration & dosage, Colorectal Neoplasms drug therapy, Thioguanine therapeutic use
- Abstract
Fifteen patients with advanced measurable colorectal carcinoma were treated with intravenous 6-thioguanine (6-TG) at a dosage of 55 mg/m2 for 5 consecutive days every 5 weeks. Only one patient had received prior adjuvant chemotherapy. No responses were detected, and eight patients had stable disease for a medium duration of three treatment cycles. Toxicity was tolerable. We conclude that 6-TG given by this dosage schedule is ineffective in treating metastatic colorectal carcinoma.
- Published
- 1992
- Full Text
- View/download PDF
34. A randomized trial of cyclophosphamide, doxorubicin, and prednisone versus cyclophosphamide, 5-fluorouracil, and prednisone in patients with metastatic breast cancer.
- Author
-
Ahmann DL, Schaid DJ, Ingle JN, Bisel HF, Schutt AJ, Buckner JC, Long HJ, and Rubin J
- Subjects
- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols adverse effects, Breast Neoplasms mortality, Cyclophosphamide administration & dosage, Doxorubicin administration & dosage, Female, Fluorouracil administration & dosage, Humans, Middle Aged, Prednisone administration & dosage, Survival Rate, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Breast Neoplasms drug therapy, Soft Tissue Neoplasms secondary
- Abstract
Ninety-four patients were entered in a clinical trial assessing the clinical activity of cyclophosphamide, doxorubicin, and prednisone (CAP) versus a combination of cyclophosphamide. 5-Fluorouracil, and prednisone (CFP) in patients with advanced breast cancer. Objective response rates were comparable, 49% for CFP and 46% for CAP. There was no statistical difference between the duration of response of the two regimens or in time to progression. Most importantly, survival differences were not apparent. Both regimens were clinically tolerable and toxicities, for the most part, were comparable. Thus, no therapeutic advantage existed for either of these polychemotherapy regimens in patients with advanced breast cancer.
- Published
- 1991
- Full Text
- View/download PDF
35. A phase III trial on the therapy of advanced pancreatic carcinoma. Evaluations of the Mallinson regimen and combined 5-fluorouracil, doxorubicin, and cisplatin.
- Author
-
Cullinan S, Moertel CG, Wieand HS, Schutt AJ, Krook JE, Foley JF, Norris BD, Kardinal CG, Tschetter LK, and Barlow JF
- Subjects
- Adenocarcinoma mortality, Adult, Aged, Aged, 80 and over, Alopecia chemically induced, Antineoplastic Combined Chemotherapy Protocols adverse effects, Cisplatin administration & dosage, Cyclophosphamide administration & dosage, Doxorubicin administration & dosage, Female, Fluorouracil administration & dosage, Fluorouracil therapeutic use, Humans, Leukopenia chemically induced, Male, Methotrexate administration & dosage, Middle Aged, Mitomycin, Mitomycins administration & dosage, Pancreatic Neoplasms mortality, Randomized Controlled Trials as Topic, Remission Induction, Survival Rate, Thrombocytopenia chemically induced, Vincristine administration & dosage, Adenocarcinoma drug therapy, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Pancreatic Neoplasms drug therapy
- Abstract
One hundred eighty-seven patients with histologically proven advanced pancreatic adenocarcinoma were randomly assigned to therapy with 5-fluorouracil (5-FU) alone, to the Mallinson regimen (combined and sequential 5-FU, cyclophosphamide, methotrexate, vincristine, and mitomycin C), or to combined 5-FU, doxorubicin, and cisplatin (FAP). Patients with both measurable and nonmeasurable disease were included and the primary study end point was survival. Among 41 patients with measurable disease, objective response rates were 7% for 5-FU alone, 21% for the Mallinson regimen, and 15% for FAP. The median interval to progression for each of the three regimens was 2.5 months. Survival curves intertwined with the median survival times for 5-FU alone and the Mallinson regimen at 4.5 months and for FAP at 3.5 months. Compared with 5-FU alone, both the Mallinson regimen and FAP produced significantly more toxicity. Neither the Mallinson regimen nor FAP can be recommended as therapy for advanced pancreatic carcinoma. Any chemotherapy for this disease should remain an experimental endeavor.
- Published
- 1990
- Full Text
- View/download PDF
36. Therapy of locally unresectable pancreatic carcinoma: a randomized comparison of high dose (6000 rads) radiation alone, moderate dose radiation (4000 rads + 5-fluorouracil), and high dose radiation + 5-fluorouracil: The Gastrointestinal Tumor Study Group.
- Author
-
Moertel CG, Frytak S, Hahn RG, O'Connell MJ, Reitemeier RJ, Rubin J, Schutt AJ, Weiland LH, Childs DS, Holbrook MA, Lavin PT, Livstone E, Spiro H, Knowlton A, Kalser M, Barkin J, Lessner H, Mann-Kaplan R, Ramming K, Douglas HO Jr, Thomas P, Nave H, Bateman J, Lokich J, Brooks J, Chaffey J, Corson JM, Zamcheck N, and Novak JW
- Subjects
- Adenocarcinoma drug therapy, Adenocarcinoma mortality, Anemia etiology, Carcinoembryonic Antigen analysis, Female, Humans, Male, Middle Aged, Nausea etiology, Pancreatic Neoplasms drug therapy, Pancreatic Neoplasms mortality, Probability, Radiotherapy adverse effects, Radiotherapy Dosage, Time Factors, Vomiting etiology, Adenocarcinoma radiotherapy, Fluorouracil therapeutic use, Pancreatic Neoplasms radiotherapy
- Abstract
One-hundred-ninety-four eligible and evaluable patients with histologically confirmed locally unresectable adenocarcinoma of the pancreas were randomly assigned to therapy with high-dose (6000 rads) radiation therapy alone, to moderate-dose (4000 rads) radiation + 5-fluorouracil (5-FU), and to high-dose radiation plus 5-FU. Median survival with radiation alone was only 51/2 months from date of diagnosis. Both 5-FU-containing treatment regimens produced a highly significant survival improvement when compared with radiation alone. Forty percent of patients treated with the combined regimens were still living at one year compared with 10% of patients treated with radiation only. Survival differences between 4000 rads plus 5-FU and 6000 rads plus 5-FU were not significant with an overall median survival of ten months. Significant prognostic variables, in addition to treatment, were pretreatment performance status and pretreatment CEA level.
- Published
- 1981
- Full Text
- View/download PDF
37. Phase II study of high-dose megestrol acetate in patients with advanced malignant melanoma.
- Author
-
Creagan ET, Schutt AJ, Ahmann DL, and Green SJ
- Subjects
- Drug Evaluation, Female, Humans, Male, Megestrol administration & dosage, Megestrol Acetate, Middle Aged, Megestrol analogs & derivatives, Melanoma drug therapy
- Published
- 1982
38. Phase II study of an aziridinylbenzoquinone (AZQ) in disseminated malignant melanoma.
- Author
-
Creagan ET, Schutt AJ, Ahmann DL, and Green SJ
- Subjects
- Aziridines administration & dosage, Aziridines adverse effects, Cyclohexenes, Drug Evaluation, Female, Humans, Male, Middle Aged, Neoplasm Metastasis, Aziridines therapeutic use, Azirines therapeutic use, Benzoquinones, Melanoma drug therapy, Skin Neoplasms drug therapy
- Abstract
Thirty-four patients with advanced malignant melanoma received AZQ (an aziridinylbenzoquinone) at a dose of 22.5 or 27.5 mg/m2/month iv. Objective regressions among 23 previously untreated and 11 previously treated patients were two and none, respectively. Hematologic toxicity was dose-limiting.
- Published
- 1982
39. Phase II clinical trial of L-alanosine in advanced upper aerodigestive cancer.
- Author
-
Creagan ET, Schutt AJ, Ingle JN, and O'Fallon JR
- Subjects
- Alanine administration & dosage, Alanine adverse effects, Alanine analogs & derivatives, Drug Evaluation, Female, Humans, Leukopenia chemically induced, Male, Stomatitis chemically induced, Thrombocytopenia chemically induced, Carcinoma, Squamous Cell drug therapy, Head and Neck Neoplasms drug therapy
- Published
- 1983
40. Cyclophosphamide, adriamycin, and 24-hour infusion of cis-diamminedichloroplatinum (II) in the management of patients with advanced head and neck neoplasms.
- Author
-
Creagan ET, O'Fallon JR, Schutt AJ, Rubin J, and Woods JE
- Subjects
- Antineoplastic Combined Chemotherapy Protocols adverse effects, Cisplatin therapeutic use, Cyclophosphamide therapeutic use, Doxorubicin therapeutic use, Female, Head and Neck Neoplasms secondary, Head and Neck Neoplasms surgery, Humans, Male, Middle Aged, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Carcinoma, Squamous Cell drug therapy, Head and Neck Neoplasms drug therapy
- Abstract
Twenty-eight patients with measurable or evaluable, regionally advanced or metastatic head and neck cancer received the combination of cyclophosphamide (C), adriamycin (ADR), and a 24-hour infusion of cis-diamminedichloroplatinum (II) (P). Most patients had received extensive prior surgery and radiation therapy, but only two had prior chemotherapy. We observed a 46% response rate (13/28) which included five complete responders and eight partial responders. Nine of the 13 patients responded within the initial month of treatment. The median response duration for the 13 responding patients was 7.5 months. Moderate to severe nausea and vomiting, and alopecia were the most significant toxicities. Myelosuppression (WBC less than 4,100 cells/mm3) occurred in 90% of patients but there were no episodes of sepsis, nor did we detect any meaningful impairment in renal function.
- Published
- 1984
- Full Text
- View/download PDF
41. A phase I study of chlorozotocin (NSC 178248).
- Author
-
Kovach JS, Moertel CG, Schutt AJ, Frytak S, O'Connell MJ, Rubin J, and Ingle JN
- Subjects
- Adult, Aged, Bone Marrow drug effects, Drug Evaluation, Half-Life, Humans, Liver drug effects, Middle Aged, Neoplasms blood, Remission, Spontaneous, Streptozocin blood, Streptozocin pharmacology, Streptozocin toxicity, Neoplasms drug therapy, Streptozocin analogs & derivatives
- Abstract
Chlorozotocin was administered by rapid intravenous infusion to 35 patients with advanced cancer on either single-day of five-consecutive-day schedules. Total doses per course ranged from 12.5 to 200 mg/m2. On either administration schedule, dose limiting toxicities were thrombocytopenia and leukopenia at total doses of 150 mg/m2 to 200 mg/m2. Repetitive courses of drug may produce progressive impairment of renal and bone marrow function. Nausea and vomiting were infrequent and mild without definite relationship to dose. Minor reversible nondose related increases in SGOT and in serum creatinine occurred at all doses on both schedules. The plasma half-life of intact N-nitroso groups averaged 9.5 minutes after rapid intravenous administration of doses up to 40 mg/m2 and 12.5 minutes after doses of 150 or 200 mg/m2. No differences between plasma half-lives were seen between identical doses given on the first and fifth days of the five-day schedule. Objective tumor regression was noted in one patient with bronchogenic large cell carcinoma and one patient with metastatic melanoma.
- Published
- 1979
- Full Text
- View/download PDF
42. Phase II trial of indicine N-oxide (INDI) in patients with advanced colorectal carcinoma.
- Author
-
Nichols WC, Moertel CG, Rubin J, Schutt AJ, and Britell JC
- Subjects
- Clinical Trials as Topic, Colonic Neoplasms pathology, Cyclic N-Oxides adverse effects, Drug Administration Schedule, Drug Evaluation, Humans, Neutropenia chemically induced, Pyrrolizidine Alkaloids adverse effects, Thrombocytopenia chemically induced, Colonic Neoplasms drug therapy, Cyclic N-Oxides therapeutic use, Pyrrolizidine Alkaloids therapeutic use
- Published
- 1981
43. Phase II trial of iv 6-thioguanine in advanced colorectal carcinoma.
- Author
-
Britell JC, Moertel CG, Kvols LK, O'Connell MJ, Rubin J, and Schutt AJ
- Subjects
- Aged, Drug Evaluation, Female, Heart drug effects, Heart physiopathology, Humans, Injections, Intravenous, Middle Aged, Myeloproliferative Disorders chemically induced, Nausea chemically induced, Thioguanine adverse effects, Vomiting chemically induced, Colonic Neoplasms drug therapy, Rectal Neoplasms drug therapy, Thioguanine therapeutic use
- Abstract
Oral 6-thioguanine (6-TG) is an S-phase antimetabolite with significant activity against acute leukemia. Preliminary reports of activity of iv 6-TG indicated significant activity against advanced colorectal cancer. We conducted a phase II study of iv 6-TG in 29 patients with advanced measurable colorectal cancer. Only one transient partial response occurred. Toxic effects included mild myelosuppression, nausea, vomiting, and minor ECG changes. We discourage further use of iv 6-TG in the dose and schedule we used to treat advanced colorectal cancer.
- Published
- 1981
44. Oral benzquinamide in the treatment of nausea and vomiting.
- Author
-
Moertel CG, Schutt AJ, Hahn RG, and O'Fallon JR
- Subjects
- Clinical Trials as Topic, Fluorouracil adverse effects, Humans, Nausea chemically induced, Prochlorperazine adverse effects, Prochlorperazine therapeutic use, Quinolizines adverse effects, Vomiting chemically induced, Nausea drug therapy, Quinolizines therapeutic use, Vomiting drug therapy
- Abstract
The clinical antiemetic effect of bezquinamide by oral route at a dosage of 100 mg 3 times daily was evaluated by a controlled double-blind method in 183 studies of patients treated with 5-fluorouracil. The incidence of nausea and vomiting in benzquinamide-treated patients was equal to that in placebo-treated patients and significantly higher than that in patients treated with prochlorperazine, 10 mg 3 times daily. Sedation was the only significant side effect observed, and this occurred at essentially equal rates in benzquinamide- and prochlorperazine-treated patients.
- Published
- 1975
- Full Text
- View/download PDF
45. Adriamycin (NSC-123127) therapy for advanced gastrointestinal cancer.
- Author
-
Frytak S, Moertel CG, Schutt AJ, Hahn RG, and Reitemeier RJ
- Subjects
- Adult, Aged, Clinical Trials as Topic, Colonic Neoplasms drug therapy, Doxorubicin adverse effects, Drug Evaluation, Female, Fluorouracil therapeutic use, Gallbladder Neoplasms drug therapy, Humans, Male, Middle Aged, Pancreatic Neoplasms drug therapy, Rectal Neoplasms drug therapy, Stomach Neoplasms drug therapy, Adenocarcinoma drug therapy, Doxorubicin therapeutic use, Gastrointestinal Neoplasms drug therapy
- Abstract
Sixty-nine patients with advanced gastrointestinal carcinomas were given adriamycin intravenously at a dose level of 40-75 mg/m once every 3 weeks. Toxic effects included nausea, vomiting, diarrhea, stomatitis, alopecia, leukopenia, thrombocytopenia, and minor ECG changes. There was a slight trend toward move severe leukopenia in patients with markedly abnormal liver function test (serum glutamic oxaloacteic transaminase and alkaline phosphatase). Of the 57 pateints with colorectal cancer treated with adriamycin, four (7%) showed partial objective responses. In a controlled comparison of adriamycin versus 5-fluorouracil (5-FU) in patients with previously untreated large bowel carcinoma, three of 23 patients (13%) receiving adriamycin showed partial objective responses as compared with six of 25 patients (24%) receiving 5-FU. The median duration of response with adriamycin was 3 months com pared to over 6 months with 5-FU. Four of eight patients with gastric carcinoma showed partial objective responses. No responses were noted in a small number of patients with pancreatic and gallbladder carcinomas. Adriamycin would not seem to have any role in the treatment of advanced colorectal carcinoma. Our results, however, would justify further evaluation of this agent in gastric carcinoma.
- Published
- 1975
46. Phase II study of recombinant leukocyte A interferon (rIFN-alpha A) in disseminated malignant melanoma.
- Author
-
Creagan ET, Ahmann DL, Green SJ, Long HJ, Rubin J, Schutt AJ, and Dziewanowski ZE
- Subjects
- Adult, Aged, Cimetidine administration & dosage, Drug Evaluation, Female, Humans, Interferon Type I adverse effects, Interferon Type I blood, Male, Middle Aged, Interferon Type I therapeutic use, Melanoma therapy
- Abstract
Thirty-one patients with disseminated malignant melanoma received intramuscular recombinant leukocyte A interferon (rIFN-alpha A), 50 X 10(6) units/m2 three times weekly for a planned treatment duration of 3 months. Seven objective regressions (23%), which ranged in duration from 3 to 11.2+ months, were observed. Forty-two percent of 12 patients who were fully active (Eastern Cooperative Oncology Group [ECOG] performance score, 0) responded compared to 11% of 19 patients with impairment of performance status (ECOG, 1-3). Prior chemotherapy did not influence response rate. For all patients the median time to progression and of survival was 2 months and 6 months, respectively. Four patients had partial regressions in soft tissue (3, 4.6 months), pulmonary (7 months), and prostatic lesions (3 months). The latter was biopsy-proven and assessed by serial computerized tomography (CT) scans. Three had complete regressions of soft tissue disease (2 patients, 6.4 and 10+ months each), and liver involvement (11.2+ months). The major toxicities were moderate to severe fatigue (87%), anorexia (58%), and confusion (23%). Performance score deteriorated in 84% of patients during the time they were receiving rIFN-alpha A. Among the 13 patients whose tumors did not progress for at least 12 weeks, 7 required dose reductions or termination of treatment due to toxicities. Hematologic and hepatic toxicity was transient and of little clinical significance. The study indicates that rIFN-alpha A has some antitumor activity accompanied by difficult side effects in patients with disseminated malignant melanoma.
- Published
- 1984
- Full Text
- View/download PDF
47. Phase I and pharmacokinetic study of menogaril administered as a 72-hour continuous i.v. infusion.
- Author
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Long HJ, Powis G, Schutt AJ, and Moertel CG
- Subjects
- Adult, Aged, Drug Evaluation, Female, Half-Life, Humans, Infusions, Intravenous, Kinetics, Male, Menogaril, Middle Aged, Nogalamycin adverse effects, Nogalamycin analogs & derivatives, Nogalamycin metabolism, Daunorubicin analogs & derivatives, Neoplasms drug therapy, Nogalamycin therapeutic use
- Abstract
Menogaril is a new anthracycline analog of nogalamycin. When administered as a 72-hour continuous iv infusion the dose-limiting toxic effect of menogaril was venous irritation at dose levels that cause only mild leukopenia and minimal gastrointestinal toxicity. Pharmacokinetic studies showed that the rise in plasma concentration during infusion was first-order, with a half-life of 11.9 hours. Total-body clearance of menogaril was 204 ml/minute/m2. There were no detectable metabolites of menogaril in plasma. Urinary excretion of unchanged menogaril was 17.3% of the dose and N-demethylmenogaril was 0.5% over 72 hours. Since menogaril does not appear to be metabolized, a high degree of tissue binding is likely.
- Published
- 1987
48. Retinoic acid-binding protein in experimental and human colon tumors.
- Author
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Sani BP, Condon SM, Brockman RW, Weiland LH, and Schutt AJ
- Subjects
- Adenocarcinoma diagnosis, Adenocarcinoma secondary, Animals, Colonic Neoplasms diagnosis, Humans, Mice, Neoplasms, Experimental metabolism, Adenocarcinoma metabolism, Colonic Neoplasms metabolism, Neoplasm Proteins metabolism, Retinol-Binding Proteins metabolism, Tretinoin metabolism
- Abstract
Retinoic acid-binding protein is present in metastatic murine colon tumors as well as in Lewis lung tumors and in lungs and brains of mice bearing these tumors; however, this protein is below the limits of detection in weakly-metastatic carcinomas and in normal lung, colon, or brains. These observations are interesting since they concern the possibility of measuring the binding protein levels of colon tumors in clinical specimens as biochemical markers in human malignancy. A total of thirty-three human colon tumors and related materials were analyzed for the presence of the binding protein. The interfering serum albumin, which nonspecifically binds retinoic acid, was eliminated by affinity chromatography. Of the twenty colon, cecum, and rectum tumors analyzed, 80% contained the binding protein in detectable amounts, and 20% showed nondetectable or marginally detectable amounts. Twenty-two percent of the human colon segments isolated from patients suspected for colon tumors contained the binding protein in readily detectable amounts, whereas 78% revealed nondetectable to marginally detectable amounts. The retinoic acid-binding protein of human colon tumor shared the same ligand specificity, thiol functions in ligand-binding, and sedimentation coefficient as the binding protein isolated from chick embryo skin. However, the human protein exhibited altered isoelectric pH.
- Published
- 1980
- Full Text
- View/download PDF
49. Corticosteroid therapy of preterminal gastrointestinal cancer.
- Author
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Moertel CG, Schutt AJ, Reitemeier RJ, and Hahn RG
- Subjects
- Clinical Trials as Topic, Dexamethasone administration & dosage, Dexamethasone adverse effects, Drug Evaluation, Gastrointestinal Hemorrhage chemically induced, Gastrointestinal Neoplasms mortality, Humans, Palliative Care, Placebos, Adenocarcinoma drug therapy, Dexamethasone therapeutic use, Gastrointestinal Neoplasms drug therapy
- Published
- 1974
- Full Text
- View/download PDF
50. A controlled evaluation of 5-fluorouracil utilizing a single injection technique.
- Author
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Ahmann DL, Moertel CG, Bisel HF, Hahn RG, Schutt AJ, and Dines DE
- Subjects
- Alopecia chemically induced, Evaluation Studies as Topic, Fluorouracil adverse effects, Gastrointestinal Diseases chemically induced, Humans, Injections, Intravenous, Leukopenia chemically induced, Neoplasm Metastasis, Stomatitis chemically induced, Thrombocytopenia chemically induced, Adenocarcinoma drug therapy, Fluorouracil administration & dosage
- Published
- 1974
- Full Text
- View/download PDF
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