Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00255762
Status:
COMPLETED
Last Update Posted:
2013-10-28
First Post:
2005-11-18
Brief Title:
Carboplatin Paclitaxel and Bevacizumab in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Carboplatin Weekly Paclitaxel and Biweekly Bevacizumab in Patients With Unresectable Stage IV Melanoma
Status:
COMPLETED
Status Verified Date:
2013-10
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:
This phase II trial is studying how well giving carboplatin and paclitaxel together with bevacizumab works in treating patients with stage IV melanoma that cannot be removed by surgery Drugs used in chemotherapy such as carboplatin and paclitaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing 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 Giving carboplatin and paclitaxel together with bevacizumab may kill more tumor cells
Detailed Description:
OBJECTIVES Primary I Determine the anti-tumor activity of carboplatin paclitaxel and bevacizumab in terms of progression-free survival in patients with unresectable stage IV melanoma
II Determine the toxicity profile of this regimen in these patients
Secondary I Determine the distribution of overall survival times in patients treated with this regimen
II Determine the response rate in patients treated with this regimen III Determine the changes in blood levels of vascular endothelial growth factor in patients treated with this regimen
IV Determine the changes in immune homeostasis in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive carboplatin IV over 30 minutes on day 1 paclitaxel IV over 1 hour on days 1 8 and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 5 years
PROJECTED ACCRUAL A total of 47 patients will be accrued for this study
II Determine the toxicity profile of this regimen in these patients
Secondary I Determine the distribution of overall survival times in patients treated with this regimen
II Determine the response rate in patients treated with this regimen III Determine the changes in blood levels of vascular endothelial growth factor in patients treated with this regimen
IV Determine the changes in immune homeostasis in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive carboplatin IV over 30 minutes on day 1 paclitaxel IV over 1 hour on days 1 8 and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 5 years
PROJECTED ACCRUAL A total of 47 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 |
|---|---|---|---|
| U10CA025224 | NIH | CTEP | httpsreporternihgovquickSearchU10CA025224 |
| NCI-2012-01823 | REGISTRY | None | None |
| CDR0000449967 | None | None | None |
| NCCTG-N047A | OTHER | None | None |
| N047A | OTHER | None | None |