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Phase II Clinical Trial of Docetaxel in Refractory Squamous Cell Carcinoma of the Cervix: A Gynecologic Oncology Group Study

Objective:A phase II study was conducted to evaluate the antitumor activity and adverse effects of docetaxel in patients with previously treated squamous cell carcinoma of the cervix. Methods:Eligible patients were to have measurable disease and not more than one prior chemotherapy regimen. Docetaxel 100 mg/m2 was administered intravenously over 1 hour. This treatment was repeated every 21 days until progression of disease or adverse effects prohibited further therapy. Results:Twenty-seven patients were entered onto this study, of whom 23 were eligible and evaluable. There were 2 (8.7%) partial responses. Eight patients (34.8%) had stable disease and 9 patients (39.1%) had increasing disease. The median time to progression was 3.8 months (range, 1.2–11.7 months), while median survival time was 7.0 months (range, 1.8–23.0 months). The most frequently reported adverse events were neutropenia, infection, gastrointestinal, and constitutional. Conclusions:Docetaxel has minimal activity in refractory squamous cell carcinoma of the cervix at the dose and schedule tested.