Ignite Creation Date:
2024-05-05 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00499694
Status:
COMPLETED
Last Update Posted:
2018-06-12
First Post:
2007-07-10
Brief Title:
Satraplatin and Bevacizumab in Treating Patients With Metastatic Prostate Cancer Previously Treated With Docetaxel
Sponsor:
Barbara Ann Karmanos Cancer Institute
Organization:
Barbara Ann Karmanos Cancer Institute
Study Overview
Official Title:
Phase II Trial of Bevacizumab and Satraplatin in Docetaxel Treated Metastatic Androgen Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA022453 | NIH | None | None |
| WSU-2006-118 | OTHER | Barbara Ann Karmanos Cancer Institute | httpsreporternihgovquickSearchP30CA022453 |