Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer

Completed · Phase 3

Conditions studied: Adenocarcinoma of the Colon, Stage III Colon Cancer

In brief

This randomized phase III trial was originally designed to compare three different combination chemotherapy regimens to see how well they work. As of September 1, 2004, the study was expanded to a total of 6 arms (the original 3 arms (A, B, C) and 3 additional arms which were the same as the first 3 but with cetuximab) in treating patients who have undergone surgery for stage III colon cancer. 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 was not known at the time this study was developed which combination chemotherapy regimen is more effective after surgery in treating colon cancer. This study had several key changes, based on the results of other phase III trials. As of 6/1/2005, patients no longer received irinotecan on this study and treatment arms B, C, E, and F were discontinued. Patients on arms B and C crossed to arm A. Patients on arms E and F crossed to arm D. Patients on arms C and F who had not gotten to irinotecan continued on arms A and D, respectively. As of 8/18/2008, pre-screening for Kirsten rat sarcoma (KRAS) status was added with mutant KRAS (or KRAS not evaluable) patients put on arm G and wild-type KRAS patients randomized between arm A and arm D. Patients on arm G were treated per physician discretion and followed for disease and survival status. KRAS was determined in a central laboratory and was process for all patients on this study. The primary endpoint of this study was modified on 8/18/2008 to focus on patients having wild-type KRAS tumors. All modifications were approved by the Central Institution Review Board, local Institutional Review Boards, NCI, and the NCCTG Data Safety Monitoring Board.

Key facts

Study ID

NCT00079274

Run by

National Cancer Institute (NCI)

People needed

3397

Starts

2004-02-01

Expected to finish

2012-11-01

Last updated by the study team

2026-06-23

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed adenocarcinoma of the colon
• Stage III disease
• No resected stage IV disease
• No rectal cancer
• Gross inferior (caudad) margin of the primary tumor must be ≥ 12 cm from the anal verge by rigid proctoscopy
• Stage III tumor must have been completely resected within the past 56 days
• Must have documented en bloc resection in patients with tumor adherence to adjacent structures
• Tumor-related obstructions and colonic perforation are allowed
• Tumor samples must be available
• At least 1 pathologically confirmed positive lymph node
• No evidence of residual involved lymph node disease
• Synchronous primary colon cancer allowed
• No distant metastatic disease
• Performance status - Eastern Cooperative Oncology Group (ECOG) 0-2
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 9 g/dL
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Creatinine ≤ 1.5 times ULN
• No uncontrolled high blood pressure
• No unstable angina
• No symptomatic congestive heart failure
• No myocardial infarction with the past 6 months
• No New York Heart Association class III or IV heart disease
• No symptomatic pulmonary fibrosis

Where it is running

• Clearview Cancer Institute — Huntsville, Alabama, United States
• Mobile Infirmary Medical Center — Mobile, Alabama, United States
• Providence Hospital — Mobile, Alabama, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States
• Banner Thunderbird Medical Center — Glendale, Arizona, United States
• Banner Desert Medical Center — Mesa, Arizona, United States
• Banner Baywood Medical Center — Mesa, Arizona, United States
• Banner Good Samaritan Medical Center — Phoenix, Arizona, United States
• Western Regional CCOP — Phoenix, Arizona, United States
• Phoenix Indian Medical Center — Phoenix, Arizona, United States
• Scottsdale Healthcare — Scottsdale, Arizona, United States
• Mayo Clinic in Arizona — Scottsdale, Arizona, United States
• Highlands Oncology Group-Bentonville — Bentonville, Arkansas, United States
• Saint Edward Mercy Medical Center — Fort Smith, Arkansas, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Veteran's Administration Medical Center — Little Rock, Arkansas, United States
• Alta Bates Medical Center-Herrick Campus — Berkeley, California, United States
• Providence Saint Joseph Medical Center — Burbank, California, United States
• Mills - Peninsula Hospitals — Burlingame, California, United States
• East Bay Radiation Oncology Center — Castro Valley, California, United States
• Eden Hospital Medical Center — Castro Valley, California, United States
• Valley Medical Oncology Consultants-Castro Valley — Castro Valley, California, United States
• City of Hope — Duarte, California, United States
• Northbay Cancer Center — Fairfield, California, United States
• Northeast Alabama Regional Medical Center — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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