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6. Phase II clinical trials with rhizoxin in breast cancer and melanoma. The EORTC Early Clinical Trials Group

Author

Hanauske, A. R., Catimel, G., Aamdal, S., ten Bokkel Huinink, W., Paridaens, R., Pavlidis, N., Kaye, S. B., te Velde, A., Wanders, J., and Verweij, J.

Subjects
Adult, Male, Antibiotics, Antineoplastic, Antibiotics, Antineoplastic/adverse effects/*therapeutic use, Lactones/adverse effects/therapeutic use, Breast Neoplasms/*drug therapy, Breast Neoplasms, Middle Aged, Hematopoiesis, Lactones, Humans, Female, Macrolides, Melanoma/*drug therapy, Hematopoiesis/drug effects, Melanoma, Research Article, Aged
Abstract

Rhizoxin is a new anti-tumour agent isolated from the pathogenic fungus Rhizopus chinensis. It has shown broad activity against murine tumour models and is also active against vinca alkaloid-resistant cells. The purpose of our studies was to determine the clinical activity of this compound in patients with advanced breast cancer and melanoma. Based on the results of a phase I study, 2.0 mg m-2 was administered as intravenous infusion over 5 min every 21 days. Nineteen patients were entered into the breast cancer phase II trial and received a total of 50 courses (median 2, range 1-6). Of these, dose reductions were performed in three courses because of leucopenia or stomatitis (1.5 mg m-2, one course; 1.45 mg m-2, two courses). Twenty-six patients were entered into the melanoma trial and received a total of 70 courses (median 2, range 1-12). No dose reductions were required. All patients were eligible for toxicity. Haematological toxicity included neutropenia CTC grade 3 (29/120 courses, 24.2%) and grade 4 (11/20 courses, 9.2%). Only drug-related CTC grade 1 thrombocytopenia was observed. Non-haematological toxicity included alopecia in all patients after two courses of treatment as well as CTC grade 3/4 stomatitis and asthenia. In the breast cancer study, one patient achieved a more than 50% tumour reduction after six cycles but was progressing after 6 weeks. Another patient showed a partial remission after the first course but was taken off the study because of CTC grade 3 skin toxicity. One patient was not evaluable for response (early death). No objective remissions were observed in 15 evaluable patients. In melanoma, no objective remissions were observed. We conclude that rhizoxin can be safely administered at 2.0 mg m-2 every 3 weeks. However, it has little activity in patients with advanced breast cancer and melanoma. Br J Cancer

Published
1996

7. Phase II study of rhizoxin in squamous cell head and neck cancer. The EORTC Early Clinical Trials Group

Author

Verweij, J., Wanders, J., Gil, T., Schöffski, P., Catimel, G., te Velde, A., and de Mulder, P. H.

Subjects
Adult, Male, Lactones, Antibiotics, Antineoplastic, Head and Neck Neoplasms, Carcinoma, Squamous Cell, Humans, Female, Macrolides, Middle Aged, Research Article, Aged
Abstract

To test the anti-tumour activity of rhizoxin in recurrent and/or metastatic squamous cell head and neck cancer, we performed a phase II study. Eligibility required histologically proven squamous cell head and neck cancer. Patients could only have received one prior chemotherapy. Patients were entered if WHO PS was < or = 2 and organ functions were normal. Treatment consisted of rhizoxin 1.5-2.0 mg m-2 i.v. bolus injection once every 3 weeks. Thirty-two patients entered the study. All were eligible, 31 were evaluable for toxicity and 25 for response. Toxicity mainly consisted of pain at the tumour site and leucocytopenia. Mild asthenia and stomatitis were also observed. Two objective partial responses, lasting 7.5 and 3.5 months, were seen. Rhizoxin at this dose and schedule has minor activity in recurrent and/or metastatic squamous cell head and neck cancer.

Published
1996

9. Phase II clinical trials with rhizoxin in breast cancer and melanoma

Author

Hanauske, A. R., Catimel, G., Aamdal, S., Huinink, W. W. Ten Bokkel, Paridaens, R., Pavlidis, Nicholas, Kaye, Stanley B., Velde, A. Te, Wanders, J., Verweij, J., and Pavlidis, Nicholas [0000-0002-2195-9961]

Subjects
Adult, Male, Neutropenia, Clinical article, Article, Lactones, Breast cancer, Antibiotics, Humans, Phase 2 clinical trial, Middle aged, Melanoma, Aged, Priority journal, Antineoplastic activity, Stomatitis, Phase ii trial, Alopecia, Leukopenia, Blood toxicity, Skin toxicity, Thrombocytopenia, Antineoplastic, Hematopoiesis, Rhizoxin, Clinical trial, Antineoplastic agent, Asthenia, Female, Intravenous drug administration, Cancer chemotherapy, Macrolides, Breast neoplasms, Human
Abstract

Rhizoxin is a new anti-tumour agent isolated from the pathogenic fungus Rhizopus chinensis. It has shown broad activity against murine tumour models and is also active against vinca alkaloid-resistant cells. The purpose of our studies was to determine the clinical activity of this compound in patients with advanced breast cancer and melanoma. Based on the results of a phase I study, 2.0 mg m-2 was administered as intravenous infusion over 5 min every 21 days. Nineteen patients were entered into the breast cancer phase II trial and received a total of 50 courses (median 2, range 1-6). Of these, dose reductions were performed in three courses because of leucopenia or stomatitis (1.5 mg m-2, one course; 1.45 mg m-2, two courses). Twenty-six patients were entered into the melanoma trial and received a total of 70 courses (median 2, range 1-12). No dose reductions were required. All patients were eligible for toxicity. Haematological toxicity included neutropenia CTC grade 3 (29/120 courses, 24.2%) and grade 4 (11/20 courses, 9.2%). Only drug-related CTC grade 1 thrombocytopenia was observed. Non-haematological toxicity included alopecia in all patients after two courses of treatment as well as CTC grade 3/4 stomatitis and asthenia. In the breast cancer study, one patient achieved a more than 50% tumour reduction after six cycles but was progressing after 6 weeks. Another patient showed a partial remission after the first course but was taken off the study because of CTC grade 3 skin toxicity. One patient was not evaluable for response (early death). No objective remissions were observed in 15 evaluable patients. In melanoma, no objective remissions were observed. We conclude that rhizoxin can be safely administered at 2.0 mg m-2 every 3 weeks. However, it has little activity in patients with advanced breast cancer and melanoma. 73 3 397 399

Published
1996

11. Randomized study of a short course of weekly cisplatin with or without amifostine in advanced head and neck cancer

Author

Planting, A.S.Th. (André), Catimel, G. (G.), Mulder, P.H.M. (Pieter) de, Graeff, A. (A.) de, Höppener, J.W.M. (Jo), Verweij, J. (Jaap), Oster, W. (W.), Vermorken, J.B. (Jan), Planting, A.S.Th. (André), Catimel, G. (G.), Mulder, P.H.M. (Pieter) de, Graeff, A. (A.) de, Höppener, J.W.M. (Jo), Verweij, J. (Jaap), Oster, W. (W.), and Vermorken, J.B. (Jan)

Published
1999
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13. A double-blind, multicentre comparison of intravenous dolasetron mesilate and metoclopramide in the prevention of nausea and vomiting in cancer patients receiving high-dose cisplatin chemotherapy

Author

Chevallier, P. (Patrice), Cappelaere, P. (P.), Splinter, T.A.W. (Ted), Fabbro, M. (M.), Wendling, J.L. (J.), Cals, L. (Laurent), Catimel, G. (G.), Giovannini, M. (Marcello), Khayat, D., Bastit, P. (P.), Claverie, N. (N.), Chevallier, P. (Patrice), Cappelaere, P. (P.), Splinter, T.A.W. (Ted), Fabbro, M. (M.), Wendling, J.L. (J.), Cals, L. (Laurent), Catimel, G. (G.), Giovannini, M. (Marcello), Khayat, D., Bastit, P. (P.), and Claverie, N. (N.)

Published
1997
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14. A double-blind, multicentre comparison of intravenous dolasetron mesilate and metoclopramide in the prevention of nausea and vomitting in cancer patients receiving high-dose Cisplatin chematherapy

Author

Chevallier, B, Cappelaere, P, Splinter, Ted, Fabbro, M, Wendling, JL, Cals, L, Catimel, G, Givanni, M, Khayat, D, Bastit, P, Claverie, N, Chevallier, B, Cappelaere, P, Splinter, Ted, Fabbro, M, Wendling, JL, Cals, L, Catimel, G, Givanni, M, Khayat, D, Bastit, P, and Claverie, N

Published
1997

15. Phase II study rhizoxin in squameus cell head and neck cancer

Author

Verweij, J., Wanders, J., Gil, Th., Schöffski, P., Catimel, G., Velde, A.A. te, Mulder, P.H.M. de, Verweij, J., Wanders, J., Gil, Th., Schöffski, P., Catimel, G., Velde, A.A. te, and Mulder, P.H.M. de

Abstract

Contains fulltext : 22715___.PDF (publisher's version ) (Open Access)

Published
1996

17. 370 Taxol® (paclitaxel) and farmorubicin® (epirubicin) in metastatic breast cancer (MBC): Preliminary results of a phase I study

Author

Dumortier A, Catimel G, Pierre Pouillart, Marc Spielmann, Pellae-Cosset B, L. Kayitalire, and Graffand N

Subjects
Cancer Research, medicine.medical_specialty, Ejection fraction, business.industry, Nausea, medicine.disease, Gastroenterology, Metastatic breast cancer, Asymptomatic, Surgery, Bolus (medicine), Oncology, Internal medicine, Heart failure, medicine, Vomiting, medicine.symptom, business, Epirubicin, medicine.drug
Abstract

TAXOL® (T) (3 hour infusion) given immediately after FARMORUBICIN® (F) (IV bolus) every 3 weeks for MBC was explored in a phase I study: Dose level TAXOL® (mg/m2) FARMORUBICIN® (mg/m2) N pts N cycles 1 110 50 3 14 2 135 50 4 19 3 175 50 6 37 4 200 50 6 29 5 200 60 3 4 6 225 50 3 6 25 109 Patients (pts) characteristics: mean age was 52 (33–68), ECOG PSO: 13, PSI: 12,17/25 pts received prior CT for their primary disease (with anthracyclines in 16 cases). In all cases, the left ventricular ejection fraction (LVEF) was ≥50% at the entry. The dose limiting toxicity evaluated at the first cycle being reached at dose level 5 (with 2 febrile neutropenias without documented infection), dose level 6 tested T 225 mg/m2 and F 50 mg/m2. So far, 78 courses have been analyzed: 26 grade 3 (33%) and 14 grade 4 (18%) neutropenias have been observed (only 3 courses with fever). Extrahematological toxicities were 1 grade 3 nausea/vomiting, 1 grade 3 asthenia, 5 grade 2 and 1 grade 3 neurotoxicities. Three pts previously treated by anthracyclines experienced cardiac toxicity: 1 myocardial ischemia, 1 heart failure and 1 asymptomatic decrease of LVEF at 41%. To date, 22 pts are evaluable for response: 9 partial (41%) (PR), 11 (50%) stabilisations. For the dose levels 3, 4 and 5, PR rate is 60%. In conclusion, TAXOL® dose escalation is still being investigated with FARMORUBICIN® kept at 50 mg/m2.

Published
1995

18. Docetaxel (Taxotere): an active drug for the treatment of patients with advanced squamous cell carcinoma of the head and neck. EORTC Early Clinical Trials Group.

Author

Catimel, G, Verweij, Jaap, Mattijssen, V, Hanauske, Axel-R, Piccart-Gebhart, Martine, Wanders, Jantien, Franklin, H, Le Bail, N, Clavel, Michel, Kaye, S B, Catimel, G, Verweij, Jaap, Mattijssen, V, Hanauske, Axel-R, Piccart-Gebhart, Martine, Wanders, Jantien, Franklin, H, Le Bail, N, Clavel, Michel, and Kaye, S B

Abstract

BACKGROUND: Docetaxel (Taxotere) is a new cytotoxic agent acting as a promoter of tubulin polymerisation with broad spectrum antitumor activity in preclinical testing. Phase I clinical trials have shown promising activity of docetaxel in patients with breast, ovarian and lung carcinomas. The objective of this open multicentre phase II study was to determine the efficacy and tolerability of this agent in patients with head and neck cancer. PATIENTS AND METHODS: Patients with proven advanced and/or recurrent squamous cell carcinoma of the head and neck without prior chemotherapy for advanced disease were eligible for this trial. Docetaxel was given at a dose of 100 mg/m2 as a 1 hour infusion every 3 weeks. Dose reductions were performed according to hematological and non-hematological toxicities. No pre-medication was given to prevent hypersensitivity reactions. RESULTS: Fourty-three patients entered this trial: 39 patients were evaluable for toxicity and 37 patients were evaluable for response. Sixty-five percent of the patients had locoregional disease, 28% had metastatic disease, and 7% had both. Twenty-five percent of the patients had previously received neo-adjuvant cisplatin-based chemotherapy. A total of 166 docetaxel courses were administered. The most frequent side-effects associated with docetaxel were alopecia (90% of the patients), asthenia (69% of the patients) and short lasting neutropenia (grade 3-4 neutropenia in 61% of the courses). Fifty-four percent of the patients experienced skin toxicity, 23% experienced hypersensitivity reaction, and 31% developed peripheral edema. Ten partial and 2 complete responses were observed, yielding a response rate of 32% (95% confidence interval 17%-47%). CONCLUSION: Docetaxel is an active drug in patients with advanced squamous cell carcinoma of the head and neck., Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, SCOPUS: ar.j, info:eu-repo/semantics/published

Published
1994

19. A phase II study of Gemcitabine (LY 188011) in patients with advanced squamous cell carcinoma of the head and neck. EORTC Early Clinical Trials Group.

Author

Catimel, G, Vermorken, Jan Baptist, Clavel, Michel, de Mulder, Pieter, Judson, I R, Sessa, C, Piccart-Gebhart, Martine, Bruntsch, U, Verweij, Jaap, Wanders, Jantien, Catimel, G, Vermorken, Jan Baptist, Clavel, Michel, de Mulder, Pieter, Judson, I R, Sessa, C, Piccart-Gebhart, Martine, Bruntsch, U, Verweij, Jaap, and Wanders, Jantien

Abstract

BACKGROUND: Gemcitabine is a new pyrimidine antimetabolite with novel metabolic properties and mechanism of action. Phase I clinical trials have demonstrated acceptable toxicity and promising antitumor activity. The objectives of this open multicenter phase II trial were to determine the efficacy and toxicity of this agent in patients with advanced head and neck cancer. PATIENTS AND METHODS: Sixty-one patients with advanced and/or recurrent squamous cell carcinoma of the head and neck were treated with Gemcitabine as a weekly 30 minutes i.v. administration for 3 consecutive weeks followed by one week rest. The Gemcitabine starting dose was 800 mg/m2/week in 47 patients (a majority being pre-treated with chemotherapy) and was later increased to 1250 mg/m2 in 14 chemotherapy-naive patients. Dose adjustments were based on hematologic and non-hematologic toxicities. RESULTS: Seven partial responses were observed among 54 evaluable patients, yielding a response rate of 13% (95% confidence interval: 4%-22%). The incidence of hematologic toxicity was low, with grade 3-4 neutropenia in less than 10% of the courses. Fifty-three percent of the patients experienced an increased in liver enzymes, mainly grade 1 or 2. Fatigue was reported by 39% of the patients, frequently associated with flu-like symptoms. CONCLUSION: Gemcitabine is a drug with documented anti-tumor activity in patients with advanced squamous cell carcinoma of the head and neck., Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't, SCOPUS: ar.j, info:eu-repo/semantics/published

Published
1994

22. A double-blind, multicentre comparison of intravenous dolasetron mesilate and metoclopramide in the prevention of nausea and vomiting in cancer patients receiving high-dose cisplatin chemotherapy

Author

Chevallier, B., primary, Cappelaere, P., additional, Splinter, T., additional, Fabbro, M., additional, Wendling, J. L., additional, Cals, L., additional, Catimel, G., additional, Giovannini, M., additional, Khayat, D., additional, Bastit, P., additional, and Claverie, N., additional

Published
1996
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29. 353 Continuous IV infusion of vinorelbine (VNB) and bolus cisplatinum (CDDP) (civic regimen) an efficient regimen in hormono resistant metastatic breast cancer (MBC), after failure of antracycline and/or paclitaxel

Author

Ray-Coquard, I., primary, Blay, J.Y., additional, Bachelot, T., additional, Berton, D., additional, Guastalla, J.P., additional, Catimel, G., additional, Philip, T., additional, Rebattu, P., additional, Droz, J.P., additional, and Biron, P., additional

Published
1995
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31. 345 A multicenter, randomized study of two schedules of paclitaxel (PTX) in patients with advanced breast cancer (ABC)

Author

Peretz, T., primary, Sulkes, A., additional, Chollet, P., additional, Gelmon, K., additional, Paridaens, R., additional, Gorbonuva, V., additional, Catimel, G., additional, Kuhnle, H., additional, ten Bokkel Huinink, W., additional, Khayat, D., additional, Dittrich, C., additional, Klaassen, U., additional, Bergh, J., additional, Wilking, N., additional, Nabholtz, J.M., additional, Calabresi, F., additional, Tubiana-Hulin, M., additional, Chazard, M., additional, Gallant, G., additional, Diergarten, K., additional, Westberg, R., additional, Bogaert, J., additional, Renard, J., additional, and Weil, C., additional

Published
1995
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36. SDZ PSC 833 in combination with doxorubicin

Author

Giaccone, G, primary, Linn, S C, additional, Catimel, G, additional, Dumortier, A, additional, Foy, M, additional, Vermorken, J B, additional, Koier, I, additional, Welink, J, additional, van der Vijgh, WJF, additional, Eeltink, C, additional, Laburte, C, additional, and Pinedo, H M, additional

Published
1994
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39. Docetaxel (Taxotere®): An active drug for the treatment of patients with advanced squamous cell carcinoma of the head and neck

Author

Catimel, G., primary, Verweij, J., additional, Mattijssen, V., additional, Hanauske, A., additional, Piccart, M., additional, Wanders, J., additional, Franklin, H., additional, Le Bail, N., additional, Clavel, M., additional, Kaye, S.B., additional, Cerny, T., additional, Hansen, H.H., additional, Kaplan, S., additional, Marty, M., additional, Pavlidis, N., additional, Schmoll, H.J., additional, Sessa, C., additional, Siegenthaler, P., additional, Ten Bokkel Huinink, W., additional, Van Oosterom, A.T., additional, and Vermorken, J.B., additional

Published
1994
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40. A phase II study of Gemcitabine (LY 188011) in patients with advanced squamous cell carcinoma of the head and neck

Author

Catimel, G., primary, Vermorken, J.B., additional, Clavel, M., additional, de Mulder, P., additional, Judson, I., additional, Sessa, C., additional, Piccart, M., additional, Bruntsch, U., additional, Verweij, J., additional, Wanders, J., additional, Franklin, H., additional, Kaye, S.B., additional, Hansen, H.H., additional, Robinson, E., additional, and Goupil, A., additional

Published
1994
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49. Phase I study of RP 49532A, a new protein-synthesis inhibitor, in patients with advanced refractory solid tumors.

Author

Catimel, Gilles, Coquard, Régis, Guastalla, Jean, Merrouche, Yacine, Bail, Nathalie, Alakl, May, Dumortier, Arlette, Foy, Maurice, Clavel, Michel, Catimel, G, Coquard, R, Guastalla, J P, Merrouche, Y, Le Bail, N, Alakl, M K, Dumortier, A, Foy, M, and Clavel, M

Subjects
ANTINEOPLASTIC agents, ASTHENIA, CLINICAL trials, COMPARATIVE studies, DOSE-effect relationship in pharmacology, ENZYME inhibitors, HYPOTENSION, IMIDAZOLES, INTRAVENOUS therapy, RESEARCH methodology, MEDICAL cooperation, NAUSEA, PROPANOLAMINES, RESEARCH, TUMORS, VOMITING, EVALUATION research, THERAPEUTICS
Abstract

Giroline (RP 49532A) is a new protein-synthesis inhibitor with broad antitumor activity in experimental models. In the present phase I study, Giroline was given by 24-h i.v. infusion every 3 weeks at doses ranging from 3 to 15 mg/m2 to 12 patients with advanced refractory solid tumors. The dose-limiting toxic effects were delayed hypotension and severe asthenia. The maximum tolerated dose (MTD) was 15 mg/m2. Transient nausea and vomiting during infusion were reported at all dose levels. Mild reversible prolongation of prothrombin time and activated partial thromboplastin time was observed in most patients at dose levels above 3 mg/m2. No antitumor activity was observed. The toxicity profile of Giroline precludes further evaluation in cancer patients. [ABSTRACT FROM AUTHOR]

Published
1995
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50. 434 A phase II study of cisplatin (CDDP) and 96 hours continuous infusion (CI) of navelbine®(NVB) in patients (PTS) with advanced squamous cell carcinoma of the head and neck (HNT)

Author

Catimel, G., Caliandro, R., Terret, C., Dumortier, A., Gignoux, B., Leval, J., Montbarbon, X., Gourmet, R., and Droz, J.P.

Abstract

Significant antitumor activity of weekly NVB administration has been previously reported in HNT. As NVB has a cycle specific activity, a CI schedule may increase its therapeutic index. We initiated a trial of CDDP (75mg/m2on d. l) and NVB (5mg iv bolus on d.1 immediately followed by 96hrs CI of 4mg/m2/d) q. 3 weeks. 14 pts (median age 59 y) were included in a first part of the study testing tolerability and efficacy of this association. 12 pts had been previously treated with CT. The median number of courses per pt was 2 (range l–6). Treatment was generally well tolerated. Hematologic toxicity consisted of neutropenia (gr 1–2: 5 pts, gr 3–4: 2 pts), anemia (gr 1–2: 6 pts, gr 3: 1 pt). No thrombopenia was observed. Non hematological toxicity consisted of nausea/vomiting (gr 1–2: 9 pts, gr 3–4: 1 pt), alopecia (gr 1–2: 3 pts), asthenia (gr 12: 2 pts), neuropathy (gr 1: 1 pt), creatinine increase (gr 1–2: 3 pts). One pt developed angina pectoris during the 4th cycle. Antitumor activity was documented in 4 pts (1 CR, 3 PRJ, giving a 29% response rate. Tumor progression was observed in 9 pts, and disease stabilisation in I pt. Present data suggest that COOP-NVB combination has significant activity in pts with recurrent and/or metastatic HNT. Since toxicity was limited, the study is ongoing with a higher NVB dose (6mg iv bolus on d. 1 immediately followed by 96 hours CI of NVB 6mg/m2/day).

Published
1995
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