Phase I trial of a 72-h continuous-infusion schedule of fazarabine

Summary Fazarabine (Ara-AC), a structural analog derived from the antitumor nucleoside cytosine arabanoside (Ara-C) and 5-azacytidine (5-AC), was studied in a phase I clinical trial. Doses ranging from 0.2 to 2.0 mg m^–2 h^–1 were given intravenously over 72 h every 28 days. The maximum tolerated dose (MDT) was 2.00 mg m^–2 h^–1. The dose-limiting toxicity was myelosuppression, with granulocytopenia being quantitatively more important than thrombocytopenia or anemia. Nonhematologic toxicity was minimal. Associated with the solvent dimethylsulfoxide (DMSO) was a bitter taste and a garlic-like odor.Supported in part by contract NOICM57739, National Cancer Institute, National Institutes of Health, Bethesda, Maryland