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Cyclophosphamide, methotrexate, and 5‐fluorouracil in a three‐drug admixture. Phase I trial of 14‐day continuous ambulatory infusion
Author(s) -
Lokich Jacob,
Bern Murray,
Anderson Norwood,
Wallach Sabina,
Moore Cherie,
Beauchamp Karen,
Williams David
Publication year - 1989
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19890301)63:5<822::aid-cncr2820630504>3.0.co;2-r
Subject(s) - medicine , cyclophosphamide , methotrexate , leukopenia , fluorouracil , bolus (digestion) , stomatitis , chemotherapy , ambulatory , gastroenterology , pharmacology , surgery
The compatibility and stability at room temperature for up to 7 days of a three‐drug admixture of cyclophosphamide, methotrexate, and 5‐fluorouracil (5‐FU) (CMF) was established permitting the practical delivery of the combination as an infusion in an ambulatory setting. Fourteen patients received 20 courses of CMF administered on a continuous infusion schedule for 14 days of a 28‐day cycle. The dose rates were fixed for 5‐FU (300 mg/M 2 /day) and methotrexate (0.75 mg/M 2 /day). The cyclophosphamide dose was escalated from 25 to 50, 75, and 100 mg/M 2 /d. Leukopenia and thrombocytopenia were observed in two of five patients receiving the maximal dose of cyclophosphamide. No other toxicities were observed including alopecia, stomatitis or liver function abnormalities. This Phase I trial suggests that the cumulative doses of cyclophosphamide, methotrexate, and 5‐FU are comparable to the maximum doses delivered as single agent infusions. Furthermore, when the infusion CMF is compared to the “standard” bolus schedule for CMF, the infusion schedule delivers 116%, 8%, and 350% of the respective three component drugs (cyclophosphamide, methotrexate, and 5‐FU).