TOXICITY OF ORAL N-METHYLFORMAMIDE IN 3 PHASE-II TRIALS - A REPORT FROM THE NATIONAL-CANCER-INSTITUTE OF CANADA CLINICAL-TRIALS GROUP

Abstract

Three National Cancer Institute of Canada phase II studied of N-methylformamide (NMF), given in a three times/week oral schedule, closed early because of frequent and occasionally severe toxicity. Eighteen of 41 (44%) cycles of treatment were not completed because of problems with NMF-induced hepatic and gastrointestinal toxicity. Several other reactions occurred, including skin rashes, abdominal pain, and gastritis, which were drug induced. One death occurred on study and was thought to be due in part to NMF toxicity. Further work exploring alternative schedules is needed before phase II studies of oral NMF can be done.