A phase II study of biweekly administration of paclitaxel in patients withrecurrent epithelial ovarian cancer

The purpose of this study was to assess the efficacy and toxicity of single agent paclitaxel administered biweekly to patients with relapse of epithel ial ovarian cancer previously treated with platinum-based regimen. Forty pa tients received an initial paclitaxel dose of 134 mg/m(2) administered intr avenously over three hours every two weeks. 283 cycles were given. All 40 patients were evaluable for toxicity, which m ainly consisted of granulocytopenia, myalgia/arthralgia, and peripheral neu ropathy. Two patients developed severe hypersensitivity reactions. Dose esc alation was possible by one level in 11 patients and by two levels in 12 pa tients, dose reductions were not necessary. Thirty-five patients were evalu ated for response. Five obtained complete response (14%), eight obtained pa rtial response (23%), and nine had stable disease (26%), while 11 patients showed progression (31%). The overall response rate was 37% (95% confidence interval 22-57%). The median duration of responses (complete and partial) was six months. Overall median time to progression and overall median survi val for eligible patients (n = 35) was 4.3 months and 11 months, respective ly. We conclude that biweekly administration of paclitaxel in recurrent epithel ial ovarian carcinoma was active with manageable toxicity.