Phase II Clinical Trial of Docetaxel in Refractory Squamous Cell Carcinoma of the Cervix

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/m 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.