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Journal of Clinical Oncology, Vol 17, Issue 3 (March), 1999: 958
© 1999 American Society for Clinical Oncology

Phase I Trial of Docetaxel With Estramustine in Androgen-Independent Prostate Cancer

Daniel P. Petrylak, Robert B. Macarthur, John O'Connor, Gary Shelton, Timothy Judge, Joshua Balog, Charles Pfaff, Emilia Bagiella, Daniel Heitjan, Robert Fine, Nancy Zuech, Ihor Sawczuk, Mitchell Benson, Carl A. Olsson

From the Divisions of Medical Oncology, Departments of Medicine, Urology, Radiology, and Biostatistics, Columbia Presbyterian Medical Center, New York, NY.

Address reprint requests to Daniel P. Petrylak, MD, Columbia Presbyterian Medical Center, 161 Fort Washington Ave, New York, NY 10032; email dpp5{at}columbia.edu

PURPOSE: To evaluate the toxicity, efficacy, and pharmacokinetics of docetaxel when combined with oral estramustine and dexamethasone in a phase I study in patients with progressive metastatic androgen-independent prostate cancer.

PATIENTS AND METHODS: Thirty-four men were stratified into minimally pretreated (MPT) and extensively pretreated (EPT) groups. Estramustine 280 mg PO tid was administered 1 hour before or 2 hours after meals on days 1 through 5, with escalated doses of docetaxel from 40 to 80 mg/m2 on day 2. Treatment was repeated every 21 days.

RESULTS: Thirty-four patients were assessable for toxicity and 33 for response. In the MPT patients, dose-limiting myelosuppression was reached at 80 mg/m2, with six patients experiencing grade 3/4 granulocytopenia. In EPT patients, escalation above 70 mg/m2 was not attempted. Fourteen MPT (70%) and six EPT (50%) patients had a >= 50% decline in serum PSA on two consecutive measurements taken at least 2 weeks apart. The overall 50% PSA response rate was 63% (95% confidence interval [CI], 28% to 81%). Of the 18 patients with bidimensionally measurable disease, five (28%; 95% CI, 11% to 54%) achieved a partial response. At the time of entry onto the study, 15 patients required narcotic analgesics for bone pain; after treatment, eight (53%) discontinued their pain medications. The area under the curve for docetaxel increased linearly from 40 to 70 mg/m2. At 80 mg/m2, the measured area under the curve was 8.37 (standard deviation, 0.724), which was significantly higher than the previously reported values.

CONCLUSION: The recommended phase II dose of docetaxel combined with estramustine is 70 mg/m2 in MPT patients and 60 mg/m2 in EPT patients. This combination is active in men with androgen-independent prostate cancer.

Presented at the Thirty-third Meeting of the American Society of Clinical Oncology, Denver, CO, May 17-20, 1997.


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