A Phase II Trial Combining Estramustine, Docetaxel And Thalidomide In Patients With Androgen-Independent Metastatic Prostate Cancer
- Determine the prostate-specific antigen response in patients with androgen-independent
metastatic adenocarcinoma of the prostate treated with docetaxel, estramustine, and
- 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
- 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
- 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
Masking: Open Label, Primary Purpose: Treatment
Avi S. Retter, MD
Eastchester Center for Cancer Care
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|
|NCI - Center for Cancer Research||Bethesda, Maryland 20892|