Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00265850
Status:
COMPLETED
Last Update Posted:
2020-05-07
First Post:
2005-12-14
Brief Title:
Cetuximab andor Bevacizumab Combined With Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase III Trial of Irinotecan 5-FU Leucovorin or Oxaliplatin 5-FU Leucovorin With Bevacizumab or Cetuximab C225 or With the Combination of Bevacizumab and Cetuximab for Patients With Untreated Metastatic Adenocarcinoma of the Colon or Rectum
Status:
COMPLETED
Status Verified Date:
2020-04
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:
PURPOSE This randomized phase III trial is studying cetuximab andor bevacizumab when given together with combination chemotherapy to compare how well they work in treating patients with metastatic colorectal cancer
RATIONALE 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 carry tumor-killing substances to them Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor Drugs used in chemotherapy such as fluorouracil leucovorin oxaliplatin and irinotecan work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving monoclonal antibodies together with combination chemotherapy may kill more tumor cells It is not yet known whether combination chemotherapy is more effective with cetuximab andor bevacizumab in treating patients with colorectal cancer
RATIONALE 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 carry tumor-killing substances to them Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor Drugs used in chemotherapy such as fluorouracil leucovorin oxaliplatin and irinotecan work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving monoclonal antibodies together with combination chemotherapy may kill more tumor cells It is not yet known whether combination chemotherapy is more effective with cetuximab andor bevacizumab in treating patients with colorectal cancer
Detailed Description:
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to physician-selected chemotherapy FOLFOX or FOLFIRI prior adjuvant chemotherapy yes vs no and prior pelvic radiotherapy yes vs no Patients were randomized to 1 of 3 treatment arms
Primary Objective
To determine if the addition of cetuximab to FOLFIRI or FOLFOX chemotherapy prolongs survival compared to FOLFIRI or FOLFOX with bevacizumab in patients with untreated advanced or metastatic colorectal cancer who have K-ras wild type tumors
Secondary Objectives
To evaluate response progression-free survival PFS time to treatment failure TTF and duration of response DR among patients with unresectable advanced metastatic colon cancer treated with bevacizumab or cetuximab in addition to chemotherapy with FOLFIRI or FOLFOX
To evaluate toxicity and in particular 60-day mortality among patients with unresectable advanced metastatic colon cancer treated with bevacizumab or cetuximab in addition to chemotherapy with FOLFIRI or FOLFOX
To describe patients with unresectable locally advanced or metastatic colorectal cancer rendered resectable with chemotherapy
There are premedication guidelines that were established for patients assigned to receive cetuximab All patients must be premedicated with diphenhydramine hydrochloride 50 mg or a similar agent IV prior to the first dose of cetuximab in an effort to prevent an infusion or hypersensitivity reaction Premedication is also recommended prior to subsequent doses but at the investigators discretion the dose of diphenhydramine or a similar agent may be reduced Pretreatment with acetaminophen may also be used
There are bevacizumab administration instructions for patients for whom surgery is being contemplated or required For patients for whom elective surgery is contemplated bevacizumab is to be discontinued for at least 8 weeks prior to surgery Bevacizumab may be resumed after at least 4 weeks following surgery Patients who undergo complete resection of metastatic disease will discontinue protocol therapy and may receive further treatment at the treating physicians discretion For patients for whom non-elective surgery is required hold bevacizumab as long as possible prior to surgery and for at least 6 weeks following surgery
Patients received a minimum of two cycles of therapy Patients were allowed to receive ancillary therapy per protocol Treatment continued until disease progression unacceptable toxicity or surgery with curative intent as planned After completion of study treatment patients are followed up to 5 years
Primary Objective
To determine if the addition of cetuximab to FOLFIRI or FOLFOX chemotherapy prolongs survival compared to FOLFIRI or FOLFOX with bevacizumab in patients with untreated advanced or metastatic colorectal cancer who have K-ras wild type tumors
Secondary Objectives
To evaluate response progression-free survival PFS time to treatment failure TTF and duration of response DR among patients with unresectable advanced metastatic colon cancer treated with bevacizumab or cetuximab in addition to chemotherapy with FOLFIRI or FOLFOX
To evaluate toxicity and in particular 60-day mortality among patients with unresectable advanced metastatic colon cancer treated with bevacizumab or cetuximab in addition to chemotherapy with FOLFIRI or FOLFOX
To describe patients with unresectable locally advanced or metastatic colorectal cancer rendered resectable with chemotherapy
There are premedication guidelines that were established for patients assigned to receive cetuximab All patients must be premedicated with diphenhydramine hydrochloride 50 mg or a similar agent IV prior to the first dose of cetuximab in an effort to prevent an infusion or hypersensitivity reaction Premedication is also recommended prior to subsequent doses but at the investigators discretion the dose of diphenhydramine or a similar agent may be reduced Pretreatment with acetaminophen may also be used
There are bevacizumab administration instructions for patients for whom surgery is being contemplated or required For patients for whom elective surgery is contemplated bevacizumab is to be discontinued for at least 8 weeks prior to surgery Bevacizumab may be resumed after at least 4 weeks following surgery Patients who undergo complete resection of metastatic disease will discontinue protocol therapy and may receive further treatment at the treating physicians discretion For patients for whom non-elective surgery is required hold bevacizumab as long as possible prior to surgery and for at least 6 weeks following surgery
Patients received a minimum of two cycles of therapy Patients were allowed to receive ancillary therapy per protocol Treatment continued until disease progression unacceptable toxicity or surgery with curative intent as planned After completion of study treatment patients are followed up to 5 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 |
|---|---|---|---|
| NCI-2009-00434 | REGISTRY | NCI Clinical Trial Reporting Program Office | httpsreporternihgovquickSearchU10CA037447 |
| U10CA037447 | NIH | None | None |
| CDR0000455161 | OTHER | None | None |