Phase II study of mitoxantrone in epithelial ovarian cancer.

Forty-six patients with advanced epithelial ovarian cancer were treated with mitoxantrone (14 mg/m2) given iv every 3 weeks. All patients had evaluable disease. Forty-one patients had had previous treatment, 38 with cisplatin. Twelve patients achieved partial response (two had had no previous treatment; ten had received previous treatment with cisplatin with or without other agents); two of the responders, both previously treated with cisplatin, achieved complete clinical remissions. Median duration of response was 24 weeks (range, 10-30). Toxicity was acceptable, with minimal subjective toxicity. Hematological toxicity was dose-limiting, but it was possible to increase the dose on one or more courses by 2 mg/m2 in 16 patients. The drug was given as a bolus, and there was no evidence of acute cardiac side effects. These data suggest that mitoxantrone has significant activity in epithelial ovarian cancer and deserves further study.