PHASE-1 STUDY OF THYMIDINE PLUS 5-FLUOROURACIL INFUSIONS IN ADVANCED COLORECTAL-CARCINOMA

  • 1 January 1979
    • journal article
    • research article
    • Vol. 63  (1) , 1-5
Abstract
To determine the minimal toxic dose of a 5 day infusion of 5-fluorouracil (5-FU) in combination with an infusion of thymidine (TdR), 12 patients received TdR at a dose of 8 mg/m2 per day for 5 1/2 days, beginning at the same time as a 5 day infusion of 5-FU at doses of 5-20 mg/kg per day. Myelosuppression was the dose limiting toxicity, and the minimal toxic dose of 5-FU was 7.5 mg/kg per day. Gastrointestinal toxicity was minimal to absent. In 8 patients with carcinoma of the colon who had received no prior chemotherapy, there were 2 patients with partial responses (at doses of 5.0 and 7.5 mg/kg per day at 5-FU), 2 patients with stable disease, 1 patient with progressive disease, and 3 patients with early death (2 drug-related deaths and 1 disease-related death). In 4 patients who had received prior 5-FU, 1 had stable disease, 1 had progressive disease, and 2 had early death (1 drug-related death). The addition of TdR to 5-FU infusions changes the dose-limiting toxicity from gastrointestinal toxicity to myelosuppression. The minimal toxic dose is decreased to approximately one third of that when 5-FU is administered alone.

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