Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00305877
Status:
COMPLETED
Last Update Posted:
2014-05-21
First Post:
2006-03-21
Brief Title:
Bevacizumab or Cetuximab And Gemcitabine Hydrochloride Capecitabine and Radiation Therapy in Treating Patients With Pacreatic Cancer That Has Been Completely Removed By Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Intergroup Randomized Phase II Study of Bevacizumab NSC 704865 or Cetuximab NSC 714692 in Combination With Gemcitabine and in Combination With Chemoradiation Capecitabine and Radiation in Patients With Completely-Resected Pancreatic Carcinoma
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 to see how well it works compared to cetuximab when given together with gemcitabine capecitabine and radiation therapy in treating patients with pancreatic cancer that has been completely removed by surgery 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 tumor cells by blocking blood flow to the tumor Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as gemcitabine and capecitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill tumor cells Giving bevacizumab or cetuximab together with gemcitabine capecitabine and radiation therapy after surgery may kill any tumor cells that remain after surgery It is not yet known whether bevacizumab is more effective than cetuximab when given together with gemcitabine capecitabine and radiation therapy in treating pancreatic cancer
Detailed Description:
PRIMARY OBJECTIVES
I To describe the toxicity profile of cetuximab and bevacizumab when combined with gemcitabine before and after capecitabine plus radiation and during capecitabine plus radiation in patients with completely-resected pancreatic carcinoma in the adjuvant setting
II To assess the safety profile of either cetuximab or bevacizumab plus gemcitabine in patients with resected pancreatic cancer
III To obtain tissue specimens from resections of patients enrolled on study for correlative studies and further evaluations
SECONDARY OBJECTIVES
I To evaluate disease-free and overall survival for patients receiving either cetuximab or bevacizumab in combination with gemcitabine before and after capecitabine plus radiation
II To assess the safety profile for patients receiving either capecitabine plus cetuximab plus radiation or capecitabine plus bevacizumab plus radiation
III To correlate changes in serum amphiregulin and TGF alpha to survival DFS and rash for patients receiving cetuximab
IV To determine the 2-year survival rate for patients receiving either cetuximab plus gemcitabine before and after capecitabine plus cetuximab plus radiation or bevacizumab plus gemcitabine before and after capecitabine plus bevacizumab plus radiation
OUTLINE This is a randomized multicenter study Patients are stratified according to degree of prior resection of the pancreatic tumor R0 vs R1 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cetuximab IV over 60-120 minutes on day 1 once weekly in weeks 1-24 gemcitabine hydrochloride IV over 30 minutes on day 1 once weekly in weeks 1-3 13-15 17-19 and 21-23 oral capecitabine twice daily on days 1-5 5 days a week in weeks 5-10 Patients also undergo radiotherapy once daily 5 days a week beginning in week 5 and continuing for approximately 5½ weeks 25 fractions
Arm II Patients receive bevacizumab IV over 60-90 minutes on day 1 in weeks 1 3 5 7 9 11 13 15 17 19 21 and 23 Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in arm I
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 3 years
I To describe the toxicity profile of cetuximab and bevacizumab when combined with gemcitabine before and after capecitabine plus radiation and during capecitabine plus radiation in patients with completely-resected pancreatic carcinoma in the adjuvant setting
II To assess the safety profile of either cetuximab or bevacizumab plus gemcitabine in patients with resected pancreatic cancer
III To obtain tissue specimens from resections of patients enrolled on study for correlative studies and further evaluations
SECONDARY OBJECTIVES
I To evaluate disease-free and overall survival for patients receiving either cetuximab or bevacizumab in combination with gemcitabine before and after capecitabine plus radiation
II To assess the safety profile for patients receiving either capecitabine plus cetuximab plus radiation or capecitabine plus bevacizumab plus radiation
III To correlate changes in serum amphiregulin and TGF alpha to survival DFS and rash for patients receiving cetuximab
IV To determine the 2-year survival rate for patients receiving either cetuximab plus gemcitabine before and after capecitabine plus cetuximab plus radiation or bevacizumab plus gemcitabine before and after capecitabine plus bevacizumab plus radiation
OUTLINE This is a randomized multicenter study Patients are stratified according to degree of prior resection of the pancreatic tumor R0 vs R1 Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cetuximab IV over 60-120 minutes on day 1 once weekly in weeks 1-24 gemcitabine hydrochloride IV over 30 minutes on day 1 once weekly in weeks 1-3 13-15 17-19 and 21-23 oral capecitabine twice daily on days 1-5 5 days a week in weeks 5-10 Patients also undergo radiotherapy once daily 5 days a week beginning in week 5 and continuing for approximately 5½ weeks 25 fractions
Arm II Patients receive bevacizumab IV over 60-90 minutes on day 1 in weeks 1 3 5 7 9 11 13 15 17 19 21 and 23 Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in arm I
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for up to 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 |
|---|---|---|---|
| U10CA021115 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021115 |
| NCI-2012-02969 | REGISTRY | None | None |
| CALGB-ECOG-E2204 | None | None | None |
| SWOG-ECOG-E2204 | None | None | None |
| ECOG-E2204 | None | None | None |
| NCCTG-ECOG-E2204 | None | None | None |
| E2204 | OTHER | None | None |
| E2204 | OTHER | None | None |