RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as satraplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving satraplatin together with bevacizumab may kill more tumor cells. PURPOSE: This clinical trial is studying how well giving satraplatin together with bevacizumab works in treating patients with metastatic prostate cancer previously treated with docetaxel.
OBJECTIVES: Primary * Determine the time to progression in patients with metastatic androgen-independent prostate cancer previously treated with docetaxel currently treated with satraplatin and bevacizumab. Secondary * Determine the toxicity of this regimen in these patients. * Assess the prostate-specific antigen (PSA) response rate in patients treated with this regimen. * Determine the overall survival of patients treated with this regimen. * Assess changes in levels of N-terminal collagen peptide (NTX) and bone-specific alkaline phosphatase (BSAP) in patients treated with this regimen. * Correlate urine NTX and serum BSAP levels with time to progression in patients treated with this regimen. OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on day 1 and oral satraplatin on days 1-5. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for 28-42 days. PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)
80 mg/m(2), Orally, Days 1-5, every 35 days
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States
Time to Progression
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. TTP is measured using Kaplan-Meier product-limit.
Time frame: Every 70 days
Toxicity, Presented as the Number of Participants With Adverse Events
Toxicity was categorized according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (version 3.0).
Time frame: Day 1 of every cycle (35 days) and Day 15 of every cycle
Percentage of Participants With Prostate-specific Antigen (PSA) Response
Prostate-specific antigen (PSA) response rate as measured by a 50% or better decrease in PSA levels
Time frame: Day 1 of every cycle (35 days) and Day 15 of every cycle
Overall Survival
Overall survival using the Kaplan-Meier method
Time frame: Followed every 3 months after treatment is discontinued
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