Combination Chemotherapy With or Without Cetuximab in Treating Patients With Stage III Colon Cancer That Was Completely Removed By Surgery

• Status: Completed
• Trial end date: 2010-06-22
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin, or fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as cetuximab, 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. Giving combination chemotherapy with or without cetuximab after surgery may kill any remaining tumor cells and keep colon cancer from coming back. It is not yet known whether giving combination chemotherapy together with cetuximab is more effective than giving combination chemotherapy alone in treating colon cancer.

PURPOSE: This randomized phase III trial is studying combination chemotherapy and cetuximab to see how well they work compared to combination chemotherapy alone in treating patients with stage III colon cancer that was completely removed by surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Federation Francophone de Cancerologie Digestive
• Treatments: Cetuximab; Fluorouracil; Leucovorin; Oxaliplatin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage III adenocarcinoma of the colon

• Must have undergone curative resection (R0) within the past 28-56 days

• No radiotherapy prior to surgery

• carcinoembryonic antigen (CEA) ≤ 1.5 times upper limit of normal (ULN) after surgery

• No rectal cancer located within 15 cm from the anal verge by endoscopy or under the peritoneal reflection at surgery

• No metastatic spread at baseline assessment

• No prior or concurrent CNS disease by physical exam

PATIENT CHARACTERISTICS:

Performance status

• WHO 0-1

Life expectancy

• At least 5 years

Hematopoietic

• WBC ≥ 3,000/mm^3

• Absolute neutrophil count ≥ 1,500/mm^3

• Platelet count ≥ 100,000/mm^3

• Hemoglobin ≥ 9 g/dL

Hepatic

• Bilirubin ≤ 1.5 times ULN

• AST and ALT ≤ 2.5 times ULN

• Alkaline phosphatase ≤ 1.5 times ULN

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No coronary artery disease

• No myocardial infarction within the past 12 months

• No high risk of uncontrolled arrhythmia

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No inflammatory bowel disease

• No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix

• No significant traumatic injury within the past 28 days

• No known hypersensitivity to any of the components of the study drugs

• No medical, geographical, sociological, psychological, or legal condition that would preclude study participation

• No peripheral neuropathy ≥ grade 1

• No other significant disease that would preclude study participation

PRIOR CONCURRENT THERAPY:

Chemotherapy

• No prior chemotherapy

Radiotherapy

• See Disease Characteristics

• No prior abdominal or pelvic irradiation

Surgery

• See Disease Characteristics

• Recovered from prior surgery

• More than 28 days since prior major surgical procedure or open biopsy

• No concurrent major surgical procedure