A phase I trial of protracted 5-fluorouracil infusion and oral calcium leucovorin. Cancer Invest 1993;11(3):247-51
Date
01/01/1993Pubmed ID
8485646DOI
10.3109/07357909309024848Scopus ID
2-s2.0-0027193745 (requires institutional sign-in at Scopus site) 4 CitationsAbstract
This phase I study of 36 patients was performed to identify the maximal tolerated dose of oral calcium leucovorin (CLV) that could be concomitantly administered with protracted 5-fluorouracil (5-FU) infusion (greater than 30 days). Administration of CLV in very small doses (5 mg p.o. q8h) with 5-FU, 200-300 mg/m2/day, resulted in excessive toxicity requiring treatment interruption in all patients. Subsequent reduction in the dose of 5-FU to 100 mg/m2/day with simultaneous administration of CLV, 5 mg p.o. q8h, decreased the toxicity and allowed for protracted administration of the combination. In subsequent patients the dose of oral CLV was increased to 22.5 mg p.o. q8h, which resulted in treatment-limiting toxicity in the majority of patients. Toxicity consisted almost exclusively of mucositis. No myelosuppression or significant organ toxicity was observed. We conclude that even low doses of oral CLV potentiate the biological effect of infusion 5-FU. If the combination is to be given on a protracted basis, 5-FU must be administered at a much smaller dosage than has been traditionally utilized.
Author List
Hansen RM, Beatty PA, Quebbeman EJ, Anderson TAuthor
Edward J. Quebbeman MD Emeritus Professor in the Surgery department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AgedDrug Administration Schedule
Female
Fluorouracil
Humans
Infusions, Intravenous
Leucovorin
Male
Middle Aged
Neoplasms









