Phase II trial of weekly paclitaxel (80 mg/m²) in platinum and paclitaxel-resistant ovarian and primary peritoneal cancers: A Gynecologic Oncology Group study

Objective.: To evaluate the activity of single agent weekly paclitaxel in patients with both platinum and paclitaxel (delivered every 3 weeks)-resistant ovarian cancer. Methods.: Forty-eight patients with platinum and paclitaxel-resistant ovarian cancer (defined as progression during, or recurrence <6 months following, their prior treatment with both agents) received single agent weekly paclitaxel (80 mg/m²/week) until disease progression (assuming acceptable toxicity). Following the initial 12 weekly doses, treatment could be given for 3 weeks, with a 1 week break. Results.: In this chemoresistant population, the objective response rate was 20.9%. Serious adverse events were relatively uncommon (neuropathy-grade 2: 21%; grade 3: 4%; and grade 3 fatigue: 8%). Conclusion.: The weekly administration of paclitaxel can be a useful management approach in women with both platinum and paclitaxel (given every 3 weeks)-resistant ovarian cancer. It would be appropriate to directly compare weekly to every 3-week paclitaxel delivery in the setting of primary chemotherapy of advanced ovarian cancer.