Phase II trial evaluating a docetaxel-capecitabine combination as treatment for hormone-refractory prostate cancer

BACKGROUND. Docetaxel is a well-recognized drug in patients with hormone-refractory prostate cancer (HRPC), either alone or combined with estramustine. In this indication, a Phase If trial was conducted investigating a docetaxel-capecitabine combination. METHODS. Forty-six patients presenting with documented HRPC were enrolled in the study. The treatment regimen consisted of docetaxel (D) at a dose of 35 mg/m(2)/week (intravenously, 3 consecutive weeks) plus oral capecitabine (C) at a dose of 625 mg/m(2) twice daily (Days 5-18) every 28 days for 4 cycles. The primary endpoint was the biological response defined as a reduction in prostate-specific antigen (PSA) level >= 50%. Secondary endpoints were overall survival, safety, and quality of life. RESULTS. Thirty of 44 assessable patients (68.2%) achieved a biological response, 14 of whom (31.8%) normalized their PSA value. The median overall survival time was 17.7 months (95% confidence interval, 15.8 to not reached). Four treatment cycles were completed by 87% of the patients. Hematologic toxicity was mild. The main Grade 3-4 toxicities were cutaneous toxicity (13.1%) and changes in nails (6.5%). Physical functioning and role scales were higher before treatment (P =.02 and P =.003, respectively), fatigue and diarrhea were more frequent during and after treatment (P =.0003 and P =.03, respectively), and pain was lower during and after treatment. CONCLUSIONS. The results of the current study demonstrated the high efficacy of the DC combination in patients with HRPC, and the associated good tolerability This combination offers a new alternative to the docetaxel-estramustine combination. Further randomized trials are warranted.