Study:
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
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 and/or bevacizumab in treating patients with colorectal
cancer.
Purpose:
This randomized phase III trial is studying cetuximab and/or bevacizumab when given
together with combination chemotherapy to compare how well they work in treating patients
with metastatic colorectal cancer.
Study Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Colorectal Cancer |
Biological: bevacizumab
Biological: cetuximab
Drug: fluorouracil
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
Drug: oxaliplatin |
Phase 3 |
Verified by
Cancer and Leukemia Group B
March, 2012
Sponsored by: Cancer and Leukemia Group B
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00265850
Study Type: Interventional
Study Design: Allocation: Randomized, Primary Purpose: Treatment
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio 44195
United States
Cleveland Clinic - Wooster
Wooster, Ohio 44691
United States
Alan P. Venook, MD., Study Chair
Charles D. Blanke, MD, FACP., Study Chair