Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091026
Status:
COMPLETED
Last Update Posted:
2014-05-15
First Post:
2004-09-07
Brief Title:
Bevacizumab and Gemcitabine Combined With Either Cetuximab or Erlotinib in Treating Patients With Advanced Pancreatic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Phase II Study of Bevacizumab NSC 704865 and Gemcitabine in Combination With Either Cetuximab NSC 714692 or OSI-774 NSC 718781 in Patients With Advanced Pancreatic 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 bevacizumab gemcitabine and cetuximab to see how well they work compared to bevacizumab gemcitabine and erlotinib in treating patients with advanced pancreatic cancer Monoclonal antibodies such as cetuximab and bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy such as gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Combining bevacizumab and gemcitabine with either cetuximab or erlotinib may kill more tumor cells
Detailed Description:
OBJECTIVES
I Compare the objective response rate in patients with advanced adenocarcinoma of the pancreas treated with bevacizumab and gemcitabine with cetuximab vs erlotinib
II Compare the toxicity of these regimens in these patients III Compare median progression-free and overall survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center University of Chicago vs other and ECOG performance status 0-1 vs 2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cetuximab IV over 1-2 hours on days 1 8 15 and 22 gemcitabine IV over 30 minutes on days 1 8 and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15
Arm II Patients receive gemcitabine and bevacizumab as in arm I Patients also receive oral erlotinib once daily on days 1-5 8-12 and 15-26
In both arms courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 54-126 patients 27-63 per treatment arm will be accrued for this study within 16 months
I Compare the objective response rate in patients with advanced adenocarcinoma of the pancreas treated with bevacizumab and gemcitabine with cetuximab vs erlotinib
II Compare the toxicity of these regimens in these patients III Compare median progression-free and overall survival of patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to participating center University of Chicago vs other and ECOG performance status 0-1 vs 2 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cetuximab IV over 1-2 hours on days 1 8 15 and 22 gemcitabine IV over 30 minutes on days 1 8 and 15 and bevacizumab IV over 30-90 minutes on days 1 and 15
Arm II Patients receive gemcitabine and bevacizumab as in arm I Patients also receive oral erlotinib once daily on days 1-5 8-12 and 15-26
In both arms courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 54-126 patients 27-63 per treatment arm will be accrued for this study within 16 months
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 |
|---|---|---|---|
| P30CA014599 | NIH | CTEP | httpsreporternihgovquickSearchP30CA014599 |
| NCI-2012-02622 | REGISTRY | None | None |
| NCI-6580 | None | None | None |
| UCCRC-13200A | None | None | None |
| CDR0000383145 | None | None | None |
| 13200A | OTHER | None | None |
| 6580 | OTHER | None | None |
| N01CM62204 | NIH | None | None |
| N01CM62203 | NIH | None | None |
| N01CM62201 | NIH | None | None |
| U01CA099118 | NIH | None | None |