A Phase II Trial of Didemnin B (NSC #335319) in Patients with Previously Treated Epithelial Ovarian Cancer A Gynecologic Oncology Group Study

Abstract

Sixteen evaluable patients with advanced or recurrent epithelial ovarian carcinoma following progression on combination chemotherapy were treated with 4.2 mg/m2 of Didemnin B (NSC #325319) intravenously every 28 days until progression of disease. All patients had prior cisplatin-containing chemotherapy. There were no responders. Seven patients had stable disease (43.7%) and nine (53.3%) had increasing disease. The toxicities were significant, consisting of nausea and vomiting in seven patients (44%), one grade 3 hepatic toxicity, and three instances of grade 4 toxicities (1 leukopenia, 1 GI, and 1 GU). When used with this schedule Didemnin B is ineffective in patients with previously treated epithelial ovarian cancer.