Gemcitabine and UFT plus oral calcium folinate: phase I study

Abstract

Gemcitabine (Gemzar) is a nucleoside analog increasingly used in the treatment of a variety of solid tumors. DNA synthesis is inhibited by gemcitabine by masked chain termination and via inhibition of ribonucleotide reductase. Synergy may exist between gemcitabine and other antimetabolites, including 5-fluorouracil. The varying patterns of dose-limiting toxicities to gemcitabine and UFT (uracil and tegafur in a 4:1 molar ratio) plus oral calcium folinate (Orzel) permit their use in combination. The primary aim of this phase I study is to determine the maximum tolerated doses of gemcitabine and UFT plus oral calcium folinate in patients with a variety of solid tumors. Only eight patients have been recruited to date, with myelosuppression being the main toxicity observed.