Prostate cancer is a common and important health issue. Although effective treatment is often available for localized disease, metastatic prostate cancer remains incurable. The initial treatment for metastatic prostate cancer often includes medical or surgical treatments that deprive the tumor of male hormones (androgens) required for growth. Although this treatment is successful for many patients, the cancer may eventually return in others. Recurrent prostate cancer may be treated with additional hormonal agents, but these agents usually do not result in long-term control of the disease. Eventually most patients with recurrent prostate cancer progress to a state where the cancer grows despite very low level of circulating male hormones known as androgen independent prostate cancer (AIPC).
Patients will undergo a screening procedure to determine eligibility of trial. During the treatment period, the patient will be given docetaxel/bevacizumab on day 1 followed by RAD001 continuously on days 2-21 and this is called a treatment cycle. Patients will be able to continue to receive multiple treatment courses as long as the cancer does not get worse and the person does not develop other problems that would prevent him from staying in the study. The final part of the research is the study completion period which includes an end of treatment visit and subsequent follow-up visits. These visits take place whenever the research medication is stopped, even if it is stopped early. For the patient's safety, he/she should at least complete the end of treatment visit.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
RAD001 oral, 2.5 mg daily RAD001 oral, 5mg daily Bevacizumab infusion (IV), 15 mg/kg every 21 days Docetaxel infusion (IV), 75 mg/m\^2 every 21 days
Westside Prostate Cancer Center, University of Southern California
Beverly Hills, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Establish a maximal tolerated or optimal biologic dose of RAD001 in combination with docetaxel/bevacizumab
Time frame: After the last patient in the cohort has completed at least two cycles of RAD001/docetaxel/bevacizumab
Evaluate the efficacy of RAD001 in combination with docetaxel/bevacizumab as determined by best overall response and progression-free survival in patients with advanced prostate cancer.
Time frame: overall survival
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