Phase I clinical trial of a new anthracycline: 4'-o-tetrahydropyranyl adriamycin.

The phase I study of a new anthracycline, 4'-o-tetrahydropyranyl adriamycin, was performed. A dose-limiting factor was leukopenia while thrombocytopenia was less frequent and a maximum tolerated dose was determined as 54 mg/m2. Mild gastrointestinal toxicities including anorexia, nausea and vomiting occurred in about half of the patients, while very minimal alopecia was seen in only one patient. A recommended dose for phase II study was established: 40 mg/m2 at 3-week intervals.