Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100841
Status:
COMPLETED
Last Update Posted:
2015-07-27
First Post:
2005-01-06
Brief Title:
Phase II Trial of FOLFOX6 Bevacizumab and Cetuximab in Patients With Colorectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of FOLFOX6 Bevacizumab and Cetuximab in Patients With Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2013-07
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:
Drugs used in chemotherapy 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 and cetuximab 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 colorectal cancer by blocking blood flow to the tumor Giving combination chemotherapy together with bevacizumab and cetuximab may kill more tumor cells This phase II trial is studying how well giving combination chemotherapy together with bevacizumab and cetuximab works in treating patients with stage IV colorectal cancer that cannot be removed by surgery
Detailed Description:
PRIMARY OBJECTIVES
I To determine the safety feasibility of administration response rates and progression free survival among chemotherapy naïve patients with advanced colorectal cancer treated with FOLFOX6 plus bevacizumab and cetuximab FBC
II To determine the survival of patients with advanced colorectal cancer treated with FBC
III To determine the safety of the current regimen in selected patients who have had prior MoAb therapy
OUTLINE This is a multicenter study
Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8 Patients also receive bevacizumab IV over 30-90 minutes oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1 3 5 and 7 Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 40-67 patients will be accrued for this study
I To determine the safety feasibility of administration response rates and progression free survival among chemotherapy naïve patients with advanced colorectal cancer treated with FOLFOX6 plus bevacizumab and cetuximab FBC
II To determine the survival of patients with advanced colorectal cancer treated with FBC
III To determine the safety of the current regimen in selected patients who have had prior MoAb therapy
OUTLINE This is a multicenter study
Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8 Patients also receive bevacizumab IV over 30-90 minutes oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1 3 5 and 7 Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed for survival
PROJECTED ACCRUAL A total of 40-67 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 |
|---|---|---|---|
| N01CM62204 | NIH | CTEP ID | httpsreporternihgovquickSearchN01CM62204 |
| NCI-6490 | OTHER | None | None |
| N01CM62201 | NIH | None | None |