Phase I--II study of 3-deazauridine in adults with acute leukemia

3-Deazauridine, a uridine analog, was administered to 36 patients with acute leukemia by both intermittent and continuous iv infusion at doses ranging from 400 to 6000 mg/m2/day x 5, repeated at 1--3-week intervals. There were no complete or partial responses but three patients showed hematologic improvement. Major toxic effects were myelosuppression, stomatitis, vomiting, diarrhea, and skin erythema. Daily doses greater than 3000 mg/m2 were associated with significantly increased toxicity, including three drug-related deaths. The recommended dose for future studies is 2500 mg/m2/day as a continuous 5-day infusion.