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Phase II Trial of Bevacizumab and Satraplatin in Docetaxel Treated Metastatic Androgen Independent Prostate Cancer
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.
Age
18 - 120 years
Sex
MALE
Healthy Volunteers
No
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States
Start Date
October 1, 2007
Primary Completion Date
November 1, 2012
Completion Date
November 1, 2012
Last Updated
June 12, 2018
31
ACTUAL participants
bevacizumab
BIOLOGICAL
satraplatin
DRUG
Lead Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
NCT04550494
NCT06842498
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05691465