A phase II study of higher dose docetaxel in androgen-independent prostate cancer

To assess the efficacy and toxicity profile of single agent docetaxel at a higher dose than previously evaluated in patients with androgen-independent prostate cancer (AIPC).

Patients with metastatic and progressive AIPC were treated with docetaxel 100 mg/m on day 1 of a 3-week cycle.

Twenty-five patients with overt and rapid symptomatic deterioration from AIPC were entered into this study. Nine men achieved a reduction in PSA of >50% and 4 >80% for an overall PSA response of 52% (95% confidence interval [CI], 31-73%). Sixty percent of men experienced pain relief. Of 16 subjects with measurable disease, 25% achieved partial response (95% CI, 0-48 months), 44% stable disease, and 31% progressed. Median time to progression was 4.5 months (95% CI, 2.9-6.1 month) and median survival was 9.3 months (95% CI, 5.7-12.9 months). Toxicity was significant and included grade 3 or greater neutropenia (76%), dehydration (16%), thrombosis (8%), confusion (4%), and death (4%).

Docetaxel is an active agent against AIPC and should be used judiciously. The side effect profile of the 100 mg/m dose was significant and cannot be recommended for everyday clinical practice.