Phase I trials of uracil-tegafur (UFT) using 5 and 28 day administration schedules: demonstration of schedule-dependent toxicities

Anti-cancer Drugs
R PazdurD H Ho

Abstract

We conducted two consecutive phase I clinical trials to identify the qualitative and quantitative toxic effects of uracil-tegafur (UFT) [Taiho Pharmaceutical Co. Ltd, Tokyo, Japan; (BMS-200604) Bristol-Myers Squibb, Princeton, NJ] administered either on a 5 or 28 day schedule and to determine the phase II trial starting doses for both schedules. Nineteen patients were entered in the 5 day schedule and 23 patients were entered on the 28 day schedule; a minimum of three patients were entered at each dose level studied. In both phase I trials, the daily UFT dose was divided into three doses administered every 8 h. Dose levels examined with the 5 day schedule were 360, 720, 900 and subsequent de-escalation to 800 mg/m2/day. Dose levels studied with the 28 day schedule were 180, 360, 450 and subsequent de-escalation to 400 mg/m2/day. With the 5 day schedule, the dose-limiting toxicity (DLT) was granulocytopenia, with four of five patients experiencing grade 4 granulocytopenia at the 900 mg/m2/day dose level. With the 28 day schedule, the DLT was diarrhea, which was noted in three of eight patients treated at 400 mg/m2/day and in three of six patients treated at 450 mg/m2/day. At these dose levels, four of these patients required pro...Continue Reading

Citations

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