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Combined 5‐fluorouracil and floxuridine administered as a 14‐day infusion. A phase I study
Author(s) -
Anderson Norwood,
Lokich Jacob,
Bern Murray,
Wallach Sabina,
Moore Cherie,
Williams David,
Umprayn Vimonrat
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<825::aid-cncr2820630505>3.0.co;2-f
Subject(s) - floxuridine , fluorouracil , medicine , chemotherapy
5‐Fluorouracil (5‐FU) and floxuridine (FUdR) were admixed in a single solution and administered via a central venous catheter on a continuous infusion schedule for 14 days. The Phase I trial design developed for admixture combinations was employed with starting doses for 5‐FU at 250 mg/m 2 /day and for FUdR at 0.075 mg/kg/day. Twenty patients and 28 courses were studied. Dose rate limiting toxicity was pseudoregional enteritis with or without stomatitis experienced by five of ten of the courses administered at the highest dose rates of the admixture components. The simultaneous delivery of the two agents results in a modest compromise of the cumulative dose delivered for FUdR. Previous Phase I studies of single agent 5‐FU and FUdR had demonstrated that the optimal dose rates for the individual agents in a 14‐day continuous 24‐hour infusion schedule is 350 mg/m 2 /d and 0.125 mg/Kg/day, respectively. The maximum dose rate of 5‐FU at 350 mg/m 2 /day for 14 days is not restricted even with the addition of FUdR at up to 0.1 mg/kg/day. The optimal dose rates for Phase II trials should be as follows: 5‐FU, 350 mg/m 2 /day and FUdR, 0.1 mg/kg/day.