A Phase II Clinical Trial of Taxotere, Emcyt and Thalidomide (TET) for the Treatment of Hormone-Refractory Prostate Cancer
OBJECTIVES:
- Determine the objective response rate in patients with hormone-refractory prostate
cancer treated with docetaxel, estramustine, and thalidomide.
- Determine the safety and toxicity of this regimen in these patients.
- Determine the efficacy of this regimen for pain control in these patients.
OUTLINE: Patients receive oral estramustine on days 1-3 and docetaxel IV over 1 hour on day
2 for 3 weeks. Treatment repeats every 4 weeks for at least 6 courses in the absence of
disease progression or unacceptable toxicity.
Patients also receive oral thalidomide once daily beginning on day 1 and continuing for 1
year in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly until disease progression.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 1 year.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Objective response rate as measured by RECIST criteria and prostate-specific antigen (PSA) response 3 months, 6 months, and 1 year after treatment
No
Richard C. Frank, MD
Study Chair
Whittingham Cancer Center
United States: Federal Government
CDR0000069081
NCT00046826
September 2001
October 2009
Name | Location |
---|---|
Carl and Dorothy Bennett Cancer Center at Stamford Hospital | Stamford, Connecticut 06904 |
Whittingham Cancer Center at Norwalk Hospital | Norwalk, Connecticut 06856 |