Oxaliplatin or paclitaxel in patients with platinum-pretreated advanced ovarian cancer: A randomized phase II study of the European Organization for Research and Treatment of Cancer Gynecology Group

Purpose: This was a multicentric, open, randomized, phase II study of singl e-agent paclitaxel and oxaliplatin to evaluate the efficacy of oxaliplatin in a relapsing progressive ovarian cancer patient population and to analyze the safety profile and impact of both agents on quality of life, time to p rogression, and survival. Patients and Methods: Eighty-six patients with platinum-pretreated advanced ovarian cancer were randomly assigned to two arms: 41 received paclitaxel at 175 mg/m(2) over 3 hours every 3 weeks, and 45 received oxaliplatin at 1 30 mg/m(2) over 2 hours every 3 weeks. For inclusion, patients had to have a performance status of 0 to 2 and to have received at least one and no mor e than two prior cisplatin- and/or carboplatin-containing chemotherapy regi mens within the last 12 months. Results: Seven confirmed responses were observed in each arm, for an overal l response rate in the total treated population of 17% (95% confidence inte rval [CI], 7% to 32%) in the paclitaxel arm and 16% (95% CI, 7% to 29%) in the oxaliplatin arm. Median time to progression was 14 weeks and 12 weeks, and overall survival wets 37 weeks and 42 weeks in the paclitaxel and oxali platin arms, respectively. Among 63 patients with a 0- to 6-month progressi on-free, platinum-free interval, there were five objective responses with p aclitaxel in 31 patients and two objective responses with oxaliplatin in 32 patients. Nine patients (22%) in the paclitaxel arm had grade 3 or 4 neutr openia (National Cancer Institute of Canada [NCIC] Common Toxicity Criteria ). Two patients (4%) experienced grade 3 thrombocytopenia in the oxaliplati n arm. Maximum grade (grade 3) NCIC neurosensory toxicity was experienced b y three patients (7%) in the paclitaxel arm find by four patients (9%) in t he oxaliplatin arm. Conclusion: Single-agent oxaliplatin at 130 mg/m(2) every 3 weeks is active with maderate toxicity in patients with cisplatin-/carboplatin-pretreated advanced ovarian cancer. (C) 2000 by American Society of Clinical Oncology.