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A Phase II Study of Weekly Docetaxel for Patients with Advanced or Recurrent Cancer of the Cervix

Background/Aims: A phase II study was conducted to assess the activity and toxicity of weekly docetaxel in patients with advanced or recurrent cancer of the cervix. Methods: Eligible patients were required to have measurable disease with adequate performance status, bone marrow, renal and hepatic function. Patients were allowed to receive chemosensitization and not more than one prior chemotherapy regimen excluding taxanes. Docetaxel 35 mg/m2 was administered intravenously weekly for 3 weeks followed by 1 week off until disease progression or adverse effects prohibited further therapy. Results: Ten patients were entered into this study, all of who were evaluable for toxicity and response. A median of 2 cycles (range 2–6) were administered. The most frequent drug-related toxicities were anemia and fatigue. There were no objective responses. Three patients had stable disease up to 6 cycles. One patient died of exsanguination from a known vaginal metastasis after completing her second cycle. The median progression-free interval was 1.7 months (range 0.9–5.8) and overall survival was 6.9 months (1.6–23.7). Conclusions: Docetaxel has limited activity in patients with recurrent cancer of the cervix at the dose and schedule tested.