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Phase I trial of 5-fluorouracil by 24-hour infusion weekly.
- Source :
-
Investigational new drugs [Invest New Drugs] 1993 May-Aug; Vol. 11 (2-3), pp. 181-5. - Publication Year :
- 1993
-
Abstract
- A novel schedule of 5-fluorouracil administration has been developed for biochemical modulation studies. In combination with the pyrimidine synthesis inhibitor PALA, 5-fluorouracil has been given as a 24-hour infusion, repeated weekly: a dose of 2600 mg/m2 is well tolerated. To identify a suitable dose of 5-fluorouracil as a single agent on this schedule, we treated 26 patients at doses ranging from 2800 to 3400 mg/m2 per week. Two-thirds of the patients had failed previous therapy, and most were symptomatic from their disease. Over half of the patients had metastatic colorectal cancer. The dose-limiting toxicity was diarrhea: Grade 3 or 4 toxicity occurred at every level tested. Twenty-two of the 26 patients required therapy interruption because of toxicity. The severity of this toxicity indicated that escalation of 5-fluorouracil on this schedule beyond the 2600 mg/m2 known to be tolerated in the PALA-containing regimen, would be impractical. Two patients, both with previously untreated colorectal cancer, had partial remissions lasting three and five months respectively. This dose-intense schedule of 5-fluorouracil administration will be explored further in large-scale randomized trials.
- Subjects :
- Adolescent
Adult
Aged
Colorectal Neoplasms blood
Colorectal Neoplasms drug therapy
Drug Administration Schedule
Gastrointestinal Diseases chemically induced
Humans
Infusions, Intravenous
Male
Middle Aged
Neoplasms blood
Neutropenia chemically induced
Pilot Projects
Fluorouracil administration & dosage
Neoplasms drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 0167-6997
- Volume :
- 11
- Issue :
- 2-3
- Database :
- MEDLINE
- Journal :
- Investigational new drugs
- Publication Type :
- Academic Journal
- Accession number :
- 8262730
- Full Text :
- https://doi.org/10.1007/BF00874152