Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy
RATIONALE: Thalidomide may stop the growth of prostate cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with thalidomide may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining docetaxel and estramustine with thalidomide in treating patients who have prostate cancer previously treated with hormone therapy.
Drug: estramustine phosphate sodium
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Clinical Trial of Taxotere, Emcyt and Thalidomide (TET) for the Treatment of Hormone-Refractory Prostate Cancer|
- Objective response rate as measured by RECIST criteria and prostate-specific antigen (PSA) response 3 months, 6 months, and 1 year after treatment [ Designated as safety issue: No ]
- Safety and toxicity as measured by CTC toxicity grading at baseline and during every visit [ Designated as safety issue: Yes ]
- Effectiveness of taxotere, emcyt, and thalidomide in pain control as measured by the pain scale at baseline and during every visit [ Designated as safety issue: No ]
|Study Start Date:||September 2001|
|Study Completion Date:||October 2009|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
- 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.
|United States, Connecticut|
|Whittingham Cancer Center at Norwalk Hospital|
|Norwalk, Connecticut, United States, 06856|
|Carl and Dorothy Bennett Cancer Center at Stamford Hospital|
|Stamford, Connecticut, United States, 06904|
|Study Chair:||Richard C. Frank, MD||Whittingham Cancer Center|