Intermittent high-dose aclarubicin in patients with advanced cancer: a phase I study with special reference to...

Aclarubicin was given iv every 3 weeks to 21 patients with a variety of solid tumors. Four dose levels were tested: 80, 100, 120, and 140 mg/m2. The median cumulative dose was 270 mg/m2 (range, 80-900). No objective responses were observed. Hematologic toxicity was dose-limiting. All patients experienced moderate to severe gastrointestinal toxicity. Five of 13 patients evaluable for cardiac function showed clinical signs and ECG changes suggestive of cardiac dysfunction. The suggested maximum dose for phase II trials is 120-140 mg/m2 iv given in an intermittent 3-week schedule.