Phase II trial of oral estramustine, oral etoposide, and intravenous paclitaxel in hormone-refractory prostate cancer

David C. Smith, Peg Esper, Myla Strawderman, Bruce Redman, Kenneth J. Pienta

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: To evaluate the combination of intravenous (IV) paclitaxel, oral estramustine, and oral etoposide in patients with advanced hormone- refractory prostate cancer. Patients and Methods: Forty patients with carcinoma of the prostate that was progressing despite hormonal therapy and who had undergone antiandrogen withdrawal (if previously treated with an antiandrogen) were enrolled onto this phase II trial. Patients were treated with oral estramustine 280 mg tid and oral etoposide 100 mg/d for 7 days, with paclitaxel 135 mg/m2 IV over 1 hour on day 2 of each 21-day treatment cycle. Patients received a maximum of six cycles of therapy. Results: Thirty- seven patients were assessable for response. Twenty-two had measurable disease at baseline; response was not assessable in six of these patients. Overall response was 45% (10 of 22 patients; 95% confidence interval [CD], 24% to 68%), and response was 63% (10 of 16) in assessable patients. Twenty- six patients had a ≥ 50% decrease from their baseline prostate-specific antigen levels during therapy, for a response rate of 65% (95% CD, 48% to 79%) by this criterion. Median duration of response was 3.2 months, with an estimated median survival of 12.8 months. Major toxicities of therapy were leukopenia (eight patients had ≥ grade 4 leukopenia) and anemia. Hematologic toxicity seemed to be associated with liver metastases. Serial measurements in 24 patients using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) showed no significant change in quality of life (QOL) as a result of therapy. Conclusion: The combination of IV paclitaxel, oral estramustine, and oral etoposide is active in patients with advanced prostate cancer. The regimen is tolerable and does not have a significant impact on QOL as measured by the FACT-P in a limited sample of patients.

Original languageEnglish (US)
Pages (from-to)1664-1671
Number of pages8
JournalJournal of Clinical Oncology
Volume17
Issue number6
DOIs
StatePublished - Jun 1999
Externally publishedYes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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