Multicenter Phase II study of estramustine phosphate plus weekly paclitaxel in patients with androgen‐independent prostate carcinoma

BACKGROUND The current study determined the efficacy and toxicity of weekly paclitaxel in combination with estramustine phosphate (EMP) in patients with androgen‐independent prostate carcinoma (AIPC). METHODS Patients with progressive AIPC received 90 mg/m2 paclitaxel by 1‐hour intravenous infusion weekly for 3 weeks, followed by a 1‐week treatment rest. Patients received 140 mg EMP orally 3 times daily on the day before, the day of, and the day after paclitaxel administration. Patients received 1 mg warfarin daily to prevent thromboembolism. RESULTS Sixty‐six patients with progressive AIPC received treatment at 29 centers. Forty‐two percent of patients had a 50% decline in prostate‐specific antigen (PSA; 95% confidence interval [CI], 30–54%). For 26 patients with bidimensionally measurable disease, the objective response rate was 15% (95% CI, 1–30%). The median time to disease progression was 6.3 months, and the median time to PSA progression was 11.4 months. The median survival period was 15.6 months. Grade 3–4 toxicities were uncommon and included thromboembolism (8%), anemia (3%), neutropenia (3%), and peripheral neuropathy (2%). There was one treatment‐related death. CONCLUSIONS This regimen of EMP plus weekly paclitaxel was an active and well tolerated treatment for patients with AIPC. Cancer 2004;100:746–50. © 2004 American Cancer Society. The current Phase II trial demonstrated that estramustine phosphate plus weekly paclitaxel is an active and well tolerated treatment regimen for patients with androgen‐independent prostate carcinoma.