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COMPLETED

NCT00079274

PHASE3

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

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

3397

Start Date

2004-02

Completion Date

2012-11

Last Updated

2026-06-23

Healthy Volunteers

Conditions

Adenocarcinoma of the Colon Stage III Colon Cancer

Interventions

DRUG

irinotecan hydrochloride

Given IV

DRUG

oxaliplatin

Given IV

DRUG

leucovorin calcium

Given IV

DRUG

fluorouracil

Given IV

BIOLOGICAL

cetuximab

Given IV

DRUG

Locally Directed Therapy

Patients determined to have mutated KRAS (or KRAS not evaluable) will be assigned to an event monitoring arm in which adjuvant therapy will be determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification will be the responsibility of the treating oncologists.

Inclusion Criteria: * 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 * No symptomatic interstitial pneumonitis * No prior allergic reaction (known sensitivity) to chimerized or murine monoclonal antibody therapy * No known allergy to platinum compounds * No documented presence of human anti-mouse antibodies (HAMA) * No active uncontrolled bacterial, viral, or systemic fungal infection * HIV negative * No clinically defined AIDS * Not pregnant or nursing * Negative pregnancy test * No men or women of childbearing potential who are unwilling to employ adequate contraception * No inadequately treated gastrointestinal bleeding * No ≥ grade 2 pre-existing peripheral sensory or motor neuropathy * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or lobular carcinoma in situ in 1 breast * No other concurrent medical condition that would preclude study participation * No concurrent biologic therapy * No prior chemotherapy for colon cancer * No other concurrent chemotherapy * No prior radiotherapy for colon cancer * No concurrent targeted agents * No prior agents directed against epidermal growth factor-receptor * No other concurrent anticancer therapy

Locations (894)

Northeast Alabama Regional Medical Center

Anniston, Alabama, United States

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

Kaiser Permanente, Fremont

Fremont, California, United States

Valley Medical Oncology Consultants-Fremont

Fremont, California, United States

California Cancer Center - North Fresno

Fresno, California, United States

Cancer Care Associates

Fresno, California, United States

California Cancer Care - Greenbrae

Greenbrae, California, United States

Sutter Health Western Division Cancer Research Group

Greenbrae, California, United States

Kaiser Permanente, Hayward

Hayward, California, United States

Saint Rose Hospital

Hayward, California, United States

Loma Linda University Medical Center

Loma Linda, California, United States

University of Southern California

Los Angeles, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Fremont - Rideout Cancer Center

Marysville, California, United States

Memorial Medical Center

Modesto, California, United States

Community Hospital of Monterey Peninsula

Monterey, California, United States

El Camino Hospital

Mountain View, California, United States

Palo Alto Medical Foundation-Camino Division

Mountain View, California, United States

Highland General Hospital