Phase 1 trial of chlorozotocin

Chlorozotocin was given to 37 patients with advanced malignant tumors in a daily x 5 schedule at 6-week intervals. Total iv doses for each course ranged from 75 to 200 mg/m². Myelosuppression was dose-limiting, with a platelet count depression regularly observed at doses of ≥ 150 mg/m²; leukopenia occurred only at the highest dose level. Nausea and vomiting were mild and uncommon. No hyperglycemia or adverse drug-related effects in renal or hepatic function were observed. No major antitumor activity occurred; however, three patients with renal cell carcinoma and one patient each with lung cancer, ovarian carcinoma, and Hodgkin's disease had minor objective decreases in tumor size. A dose range of 150-200 mg/m² iv for each 5-day course is recommended for phase II studies.