Study:
A Randomized Phase III Trial of Oxaliplatin (OXAL) Plus 5-Fluorouracil (5-FU)/Leucovorin (CF) With or Without Cetuximab (C225) After Curative Resection for Patients With Stage III Colon Cancer
Rationale:
Drugs used in chemotherapy, such as irinotecan, fluorouracil, leucovorin, and
oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or
die. Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or
deliver tumor-killing substances to them without harming normal cells. Combining more than
one chemotherapy drug with monoclonal antibody therapy and giving them after surgery may kill
any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more
effective after surgery in treating colon cancer. (As of 6/1/2005, patients will no longer
receive irinotecan on this study.)
Purpose:
This randomized phase III trial is comparing three different combination chemotherapy
regimens to see how well they work when given with or without cetuximab in treating patients
who have undergone surgery for stage III colon cancer. (As of 6/1/2005, patients will no
longer receive irinotecan on this study.) Drugs used in chemotherapy, such as irinotecan
hydrochloride, fluorouracil, leucovorin calcium, and oxaliplatin, work in different ways to
stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as
cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to
them without harming normal cells. Combining more than one chemotherapy drug with monoclonal
antibody therapy and giving them after surgery may kill any remaining tumor cells. It is not
yet known which combination chemotherapy regimen is more effective after surgery in treating
colon cancer. (As of 6/1/2005, patients will no longer receive irinotecan on this study.
Study Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Adenocarcinoma of the Colon
Stage III Colon Cancer |
Drug: irinotecan hydrochloride
Drug: oxaliplatin
Drug: leucovorin calcium
Drug: fluorouracil
Biological: cetuximab |
Phase 3 |
Verified by
National Cancer Institute (NCI)
August, 2012
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov identifier: NCT00079274
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Cleveland Clinic Cancer Center Independence
Independence, Ohio 44131
United States
Cleveland Clinic Wooster Specialty Center
Wooster, Ohio 44691
United States
Frank Sinicrope., Principal Investigator