Docetaxel, Estramustine, and Thalidomide in Treating Patients With Prostate Cancer Previously Treated With Hormone Therapy
- Conditions
- Prostate Cancer
- Registration Number
- NCT00046826
- Lead Sponsor
- Nuvance Health
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective response rate as measured by RECIST criteria and prostate-specific antigen (PSA) response 3 months, 6 months, and 1 year after treatment
- Secondary Outcome Measures
Name Time Method Safety and toxicity as measured by CTC toxicity grading at baseline and during every visit Effectiveness of taxotere, emcyt, and thalidomide in pain control as measured by the pain scale at baseline and during every visit
Trial Locations
- Locations (2)
Whittingham Cancer Center at Norwalk Hospital
🇺🇸Norwalk, Connecticut, United States
Carl and Dorothy Bennett Cancer Center at Stamford Hospital
🇺🇸Stamford, Connecticut, United States