Phase II study of oxaliplatin in platinum-resistant and refractory ovarian cancer: A gynecologic group study

Purpose: A phase II study was conducted to determine the efficacy of oxaliplatin therapy in patients with platinum-resistant or refractory epithelial ovarian carcinoma. Materials and Methods: Eligible patients were to receive oxaliplatin 130 mg/m² intravenously over 2 hours, every 21 days, until progression of disease or adverse effects prohibited further therapy. Results: Of 25 patients entered onto the study, 23 were eligible and assessable. There were no patients with complete response. One patient (4.3%) achieved a partial response, with a response duration of 6.4 months. Nine patients (39.1%) experienced stable disease, with a median duration of 5.6+ months (range, 1.8 to 13.1months). The most frequently reported drug-related toxicities were hematologic, gastrointestinal, and neurologic. Conclusion: Oxaliplatin as a single agent has minimal activity in patients with platinum-resistant or refractory ovarian cancer at the dosage and schedule tested. However, future studies of oxaliplatin combined with other active agents in women with platinum-naive or platinum-sensitive epithelial ovarian carcinoma may be indicated.