Phase I trial of uracil-tegafur (UFT) plus oral leucovorin: 28-day schedule

Cancer Investigation
R PazdurD H Ho

Abstract

UFT [Taiho Pharmaceutical Co. Ltd., Tokyo, Japan; (BMS-200604), Bristol-Myers Squibb, Princeton, NJ], a fluorouracil prodrug, is an oral 4:1 molar concentration of uracil plus tegafur. This study examined the dose-limiting toxic effects and maximum tolerated dose of UFT plus leucovorin administered for 28 consecutive days followed by a 7-day rest period. A course of therapy was repeated every 35 days. UFT dose levels examined were 200 mg/m2/day, with planned escalations to 250, 300, 350, and 400 mg/m2/day; the leucovorin dose remained at 150 mg/day. Three patients were initially enrolled at each UFT dose level. The total daily doses of both UFT and leucovorin were divided into three doses administered every 8 hr. Diarrhea became the dose-limiting toxicity at 400 mg/m2/day UFT, with grade 3 diarrhea noted in 2 of the 3 patients receiving that dose. To further define a phase II UFT starting dose, 3 additional patients were entered at the 350 mg/m2 level; 3 of the 6 patients treated at this level developed grade 3 nonhematological toxic effects. No partial or complete responses were observed. The recommended phase II UFT starting dose is 300 mg/m2/day plus 150 mg/day leucovorin. Since neutropenia, significant mucositis, and "hand-...Continue Reading

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Citations

Nov 16, 2006·Diseases of the Colon and Rectum·Junichi SakamotoMichiya Kobayashi
Dec 21, 2000·Current Oncology Reports·M E RoyceR Pazdur
Nov 27, 2001·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·V AlonsoA Antón
Nov 27, 2002·Surgical Oncology·Lakshmi Rajdev, Steven M Keller
Mar 13, 2002·Drugs & Aging·K Wellington, K L Goa
Jan 30, 2003·European Journal of Internal Medicine·Jean Emmanuel KurtzPatrick Dufour
Nov 4, 2000·Expert Opinion on Investigational Drugs·R L Schilsky, H L Kindler
Dec 7, 2000·Cancer Investigation·N L Lewis, N J Meropol
Jun 16, 2001·Current Problems in Cancer·C H Takimoto
Oct 5, 2001·Expert Opinion on Pharmacotherapy·R Jones, C Twelves
Oct 16, 1999·American Journal of Clinical Oncology·J S Macdonald

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