Status:
COMPLETED
Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Collaborating Sponsors:
Eastern Cooperative Oncology Group
Conditions:
Adenocarcinoma of the Colon
Stage III Colon Cancer
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief 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 tot...
Detailed Description
PRIMARY OBJECTIVES: I. Disease-free Survival (Arms A and D: Wild-type KRAS Patients) SECONDARY OBJECTIVES: I. Disease-free Survival (Arms A and D: Mutant KRAS Patients) II. Disease-free Survival II...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
3397 Patients enrolled
Trial Details
Trial ID
NCT00079274
Start Date
February 1 2004
End Date
November 1 2012
Last Update
May 13 2020
Active Locations (894)
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1
Northeast Alabama Regional Medical Center
Anniston, Alabama, United States, 36202
2
Clearview Cancer Institute
Huntsville, Alabama, United States, 35805
3
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36607
4
Providence Hospital
Mobile, Alabama, United States, 36608