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Phase II Study of Oxaliplatin in Platinum-Resistant and Refractory Ovarian Cancer: A Gynecologic Group Study

Paula M. Fracasso, John A. Blessing, Mark A. Morgan, Anil K. Sood, James S. Hoffman

From the Washington University School of Medicine, St Louis, MO; Gynecologic Oncology Group Statistical and Data Cancer; Roswell Park Cancer Institute, Buffalo, NY; Department of Gynecologic Oncology, University of Pennsylvania Cancer Center, Philadelphia, PA; Division of Gynecologic Oncology, University of Iowa Hospitals and Clinics, Iowa City, IA; and Division of Gynecologic Oncology, University of Connecticut School of Medicine, Farmington, CT.

Address reprint requests to Paula M. Fracasso, MD, PhD, Washington University School of Medicine, Campus Box 8056, 660 South Euclid, St Louis, MO 63130; email: fracasso{at}im.wustl.edu.

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-naïve or platinum-sensitive epithelial ovarian carcinoma may be indicated.

Supported by National Cancer Institute grants to the Gynecologic Oncology Group Administrative Office (CA 27469) and the Gynecologic Oncology Group Statistical Office (CA 37517), and a Clinical Oncology Career Development Award from the American Cancer Society to P.M.F.

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