Satraplatin and Bevacizumab in Treating Patients With Metastatic Prostate Cancer Previously Treated With Docetaxel
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|ClinicalTrials.gov Identifier: NCT00499694|
Recruitment Status : Completed
First Posted : July 11, 2007
Results First Posted : August 25, 2014
Last Update Posted : June 12, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Biological: bevacizumab Drug: satraplatin||Not Applicable|
- Determine the time to progression in patients with metastatic androgen-independent prostate cancer previously treated with docetaxel currently treated with satraplatin and bevacizumab.
- 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 (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Bevacizumab and Satraplatin in Docetaxel Treated Metastatic Androgen Independent Prostate Cancer|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Experimental: Bevacizumab and Satraplatin
Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)
Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days
10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)
Other Name: Avastin ®
80 mg/m(2), Orally, Days 1-5, every 35 days
- Time to Progression [ Time Frame: Every 70 days ]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.
- Toxicity, Presented as the Number of Participants With Adverse Events [ Time Frame: Day 1 of every cycle (35 days) and Day 15 of every cycle ]Toxicity was categorized according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (version 3.0).
- Percentage of Participants With Prostate-specific Antigen (PSA) Response [ Time Frame: Day 1 of every cycle (35 days) and Day 15 of every cycle ]Prostate-specific antigen (PSA) response rate as measured by a 50% or better decrease in PSA levels
- Overall Survival [ Time Frame: Followed every 3 months after treatment is discontinued ]Overall survival using the Kaplan-Meier method
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00499694
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201-1379|
|Veterans Affairs Medical Center - Detroit|
|Detroit, Michigan, United States, 48201|
|Study Chair:||Ulka N. Vaishampayan, MD||Barbara Ann Karmanos Cancer Institute|