Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077298
Status:
COMPLETED
Last Update Posted:
2015-04-15
First Post:
2004-02-10
Brief Title:
Bevacizumab and Cetuximab With or Without Irinotecan in Treating Patients With Irinotecan-Refractory Metastatic Colorectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Study of Bevacizumab in Combination With Cetuximab Plus Irinotecan or in Combination With Cetuximab Alone in Irinotecan-Refractory Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2012-12
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 randomized phase II trial is studying giving bevacizumab and cetuximab together with irinotecan to see how well it works compared to giving bevacizumab and cetuximab alone in treating patients with irinotecan-refractory metastatic colorectal cancer Monoclonal antibodies such as cetuximab and 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 deliver tumor -killing substances to them Drugs used in chemotherapy such as irinotecan also work in different ways to kill tumor cells or stop them from growing Giving cetuximab and bevacizumab together with irinotecan may improve the ability to block tumor growth
Detailed Description:
PRIMARY OBJECTIVES
I Evaluate time to tumor progression in patients with irinotecan-refractory metastatic colorectal cancer treated with bevacizumab and cetuximab with or without irinotecan
II Evaluate objective response rate in patients treated with these regimens III Evaluate overall survival of patients treated with these regimens IV Evaluate safety tolerability and adverse event profiles of these regimens in these patients
V Correlate a panel of molecular markers eg those involved in the epidermal growth factor receptor signaling pathway angiogenic pathway and irinotecan metabolism with clinical outcome in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center ECOG performance status 0 vs 1 and albumin 30 gdL vs 30 gdL Patients are randomized to 1 of 2 treatment arms
ARM A Patients receive cetuximab IV over 1-2 hours on days 1 8 15 22 29 and 36 bevacizumab IV over 30-90 minutes on days 1 15 and 29 OR on days 1 and 22 and irinotecan IV over 30-90 minutes at the same dose and schedule that the patient previously received beginning on day 1
ARM B Patients receive cetuximab as in Arm A and bevacizumab IV over 30-90 minutes on days 1 15 and 29
NOTE Bevacizumab is given on day 2 instead of day 1 of course 1 and is given on day 1 of subsequent courses
In both arms courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed for 3 years
I Evaluate time to tumor progression in patients with irinotecan-refractory metastatic colorectal cancer treated with bevacizumab and cetuximab with or without irinotecan
II Evaluate objective response rate in patients treated with these regimens III Evaluate overall survival of patients treated with these regimens IV Evaluate safety tolerability and adverse event profiles of these regimens in these patients
V Correlate a panel of molecular markers eg those involved in the epidermal growth factor receptor signaling pathway angiogenic pathway and irinotecan metabolism with clinical outcome in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center ECOG performance status 0 vs 1 and albumin 30 gdL vs 30 gdL Patients are randomized to 1 of 2 treatment arms
ARM A Patients receive cetuximab IV over 1-2 hours on days 1 8 15 22 29 and 36 bevacizumab IV over 30-90 minutes on days 1 15 and 29 OR on days 1 and 22 and irinotecan IV over 30-90 minutes at the same dose and schedule that the patient previously received beginning on day 1
ARM B Patients receive cetuximab as in Arm A and bevacizumab IV over 30-90 minutes on days 1 15 and 29
NOTE Bevacizumab is given on day 2 instead of day 1 of course 1 and is given on day 1 of subsequent courses
In both arms courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed for 3 years
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 |
|---|---|---|---|
| N01CM17102 | NIH | CTEP | httpsreporternihgovquickSearchN01CM17102 |
| NCI-2012-01445 | REGISTRY | None | None |
| MSKCC-03135 | None | None | None |
| NCI-6444 | None | None | None |
| CDR0000350086 | None | None | None |
| 03-135 | OTHER | None | None |
| 6444 | OTHER | None | None |
| N01CM17105 | NIH | None | None |
| N01CM17101 | NIH | None | None |
| N01CM17103 | NIH | None | None |