Docetaxel, Estramustine, and Thalidomide in Treating Patients With Androgen-Independent Metastatic Adenocarcinoma of the Prostate

Phase 2

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00083005
• Lead Sponsor: National Institutes of Health Clinical Center (CC)

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and estramustine, work in different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor. Giving chemotherapy together with thalidomide may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving docetaxel and estramustine together with thalidomide works in treating patients with androgen-independent metastatic adenocarcinoma (cancer) of the prostate.

Detailed Description

OBJECTIVES:

Primary

* Determine the prostate-specific antigen response in patients with androgen-independent metastatic adenocarcinoma of the prostate treated with docetaxel, estramustine, and thalidomide.

Secondary

* Determine the survival duration in patients treated with this regimen.

* Determine the pharmacokinetics of both docetaxel and thalidomide in patients treated with this regimen.

* Determine whether any pharmacodynamic relationships exist between plasma concentrations of docetaxel and/or thalidomide and clinical activity or toxicity of this regimen in these patients.

* Determine the existence of and quantification of circulating prostate cancer cells in patients before and after treatment with this regimen.

* Determine genotype, with regard to cytochrome P450 2C19 polymorphism, in patients treated with this regimen.

* Correlate genotype with pharmacokinetics and efficacy of this regimen in these patients.

* Determine the changes in molecular markers of angiogenesis (including, but not limited to, serum and urine vascular endothelial growth factor) in patients before and after treatment with this regimen.

* Determine the toxicity profile of this regimen in these patients.

OUTLINE: This is an open-label study.

Patients receive docetaxel IV over 30 minutes on days 2, 9, and 16, oral thalidomide once daily on days 1-28, and oral estramustine three times daily on days 1-3, 8-10, and 15-17. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 33-60 patients will be accrued for this study within 11-20 months.

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2004-05-14
• Study First Submitted QC: 2004-05-14
• Study First Posted: 2004-05-17
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-14
• Last Update Posted: 2012-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PSA response
Toxicity

Secondary Outcome Measures

Name	Time	Method
Survival

Trial Locations

Locations (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office; 🇺🇸 Bethesda, Maryland, United States

NCI - Center for Cancer Research; 🇺🇸 Bethesda, Maryland, United States