Cisplatin plus gemcitabine in platinum-refractory ovarian or primary peritoneal cancer: A phase II study of the Gynecologic Oncology Group

Objectives. To evaluate the safety and efficacy of cisplatin plus gemcitabine in persistent or recurrent platinum-resistant ovarian and primary peritoneal cancer. Study Design. Eligible, consenting subjects with measurable disease and one prior platinum-based regimen, but no prior gemcitabine, were to receive intravenous cisplatin followed by gemcitabine on days 1 and 8 every 28 days. Results. Between December 2000 and March 2003, 59 patients were enrolled from 24 institutions; two were ineligible. During the first stage of accrual, 27 subjects received cisplatin 30 mg/m(2) and gemcitabine 750 mg/m(2). In the second stage, gemcitabine was reduced to 600 mg/m(2) because of hematologic toxicity at the higher dose. There were 4 complete and 5 partial responses for an overall response rate of 16% (9/57). Thirty-one women (54%) had stable disease. Median time to progression was 5.4 months. Overall survival was 14.9+ months. Grade 4 toxicities were hematologic, except one cutaneous reaction. Conclusions. Cisplatin plus gemcitabine, in the doses and schedule employed, has modest activity in this patient population. (c) 2006 Elsevier Inc. All rights reserved.