Phase II trial to study the effectiveness of combination chemotherapy plus monoclonal antibody therapy in treating patients who have metastatic prostate cancer that has not responded to previous hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab may stop the growth of cancer cells by stopping blood flow to the tumor. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.
PRIMARY OBJECTIVES: I. To determine time to objective progression, response rate (objective and PSA response) and duration of response in men with hormone refractory prostate cancer treated with estramustine, docetaxel and bevacizumab. II. To determine the toxicity of this regimen in men with hormone refractory prostate cancer. III. To study the relationship of baseline VEGF levels in urine and plasma and changes in these levels to response and duration of response to treatment with bevacizumab, docetaxel and estramustine. OUTLINE: Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour followed by bevacizumab IV over 30-90 minutes on day 2. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed at least every 3 months for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Cancer and Leukemia Group B
Chicago, Illinois, United States
Time to objective progression
The Kaplan-Meier method will be used to estimate the time to disease progression.
Time frame: From the initiation of treatment to the date of progressive disease, assessed up to 2 years
Response rates (PSA and objective)
Response rates will be analyzed using both objective (CR and PR) and serological parameters. The Kaplan-Meier method will be used to estimate the response (objective and PSA) duration.
Time frame: Up to 2 years
Toxicity as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 2.0
Time frame: Up to 2 years
Overall survival
The Kaplan-Meier method will be used to estimate the overall survival.
Time frame: Up to 2 years
Duration of response
Duration of PSA response is the date from the first 50% decline (or 75% decline) in PSA to the date when the patient met the criteria for progressive disease.
Time frame: From the date of the first CR or PR to the date that the patient had progressive disease, assessed up to 2 years
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