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Brief Title: Combination Chemotherapy Plus Bevacizumab in Treating Patients With Metastatic Prostate Cancer
Official Title: A Phase II Study Of Estramustine, Docetaxel, And Bevacizumab (IND # 7921, NSC # 704865) In Men With Hormone Refractory Prostate Cancer
Study ID: NCT00016107
Brief Summary: 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.
Detailed Description: 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.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Cancer and Leukemia Group B, Chicago, Illinois, United States
Name: Joel Picus
Affiliation: Cancer and Leukemia Group B
Role: PRINCIPAL_INVESTIGATOR