Phase I trial of 4-demethoxydaunorubicin with single i.v. doses.

Sixteen adult patients with a variety of solid tumors entered a phase I trial with 4-demethoxydaunorubicin, a new analogue of daunorubicin. The drug was given as a single i.v. dose of 5-18 mg/m2 repeated every 3-4 weeks. Myelosuppression, especially leucopenia, was dose-limiting. Other toxic effects included mild to moderate nausea and vomiting. The maximum tolerated dose for ambulatory treatment was 18 mg/m2, and 15 mg/m2 every 3-4 weeks is proposed as a starting dose for phase II trials in solid tumors.