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A single-arm Phase II study evaluating combination chemotherapy utilizing oral etoposide and irinotecan for platinum-resistant and taxane-pretreated ovarian cancer has started. The aim of this study is to evaluate the efficacy and safety of this regimen as a test arm regimen in a subsequent Phase III trial. Patients with platinum-resistant and taxane-pretreated ovarian cancer are given etoposide at 50 mg/m(2) p.o. from days 1 to 21 and irinotecan 70 mg/m(2) i.v. at days 1 and 15, repeated every 28 days, up to six cycles. A total of 60 patients will be enrolled at 36 institutions. The primary endpoint is response rate. The secondary endpoints include adverse events and progression-free and overall survival.

japanese journal of clinical oncology

Phase II Study of Oral Etoposide and Intravenous Irinotecan for Patients with Platinum-resistant and Taxane-pretreated Ovarian Cancer: Japan Clinical Oncology Group Study 0503