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

Abstract

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.

• Authors: David J Vaughn, Archie W Brown Jr, W Graydon Harker, Sang Huh, Lance Miller, David Rinaldi, Fairooz Kabbinavar
• Journal: Cancer (Cancer) Vol. 100 Issue 4 Pg. 746-50 (Feb 15 2004) ISSN: 0008-543X [Print] United States
• PMID: 14770430 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 2004 American Cancer Society.

Chemical References

• Androgens
• Estramustine
• Paclitaxel

Topics

• Aged
• Aged, 80 and over
• Androgens (pharmacology)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Carcinoma (drug therapy, pathology)
• Drug Administration Schedule
• Estramustine (administration & dosage)
• Humans
• Infusions, Intravenous
• Male
• Middle Aged
• Paclitaxel (administration & dosage)
• Prostatic Neoplasms (drug therapy, pathology)
• Survival Analysis
• Treatment Outcome