Phase I clinical study of dihydroxyanthracenedione administered on a 5-day iv schedule

Dihydroxyanthracenedione is a new anthraquinone derivative with a wide spectrum of antitumor activity in experimental systems. A phase I clinical study was conducted using a 5-day iv schedule repeated every 3-4 weeks. Thirty-three adults with advanced refractory solid tumors received dihydroxyanthracenedione at daily doses ranging from 0.5 to 4 mg/m2. Neutropenia and, to a lesser degree, thrombocytopenia were dose-limiting toxic effects, although they were of brief duration. Other toxic effects were negligible. There were no complete or partial remissions in this study. We recommend that phase II studies of dihydroxyanthracenedione on a 5-day schedule use an initial daily dose of 4 mg/m2 for good-risk patients or 2-3 mg/m2 for poor-risk patients. Treatment courses can be repeated at 4-week intervals.