A Phase I Trial of Protracted 5-Fluorouracil Infusion and Oral Calcium Leucovorin
作者:
HansenRichard M.,
BeattyPeter A.,
QuebbemanEdward J.,
AndersonTom,
期刊:
Cancer Investigation
(Taylor Available online 1993)
卷期:
Volume 11,
issue 3
页码: 247-251
ISSN:0735-7907
年代: 1993
DOI:10.3109/07357909309024848
出版商: Taylor&Francis
数据来源: Taylor
摘要:
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 mye-losuppression 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.
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