Combination Chemotherapy With or Without Cetuximab in Treating Patients With Stage III Colon Cancer That Was Completely Removed By Surgery
Condition: Colorectal Cancer
MeSH terms: Colonic Neoplasms
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the disease-free survival rates in patients with completely resected stage III
           colon cancer treated with adjuvant oxaliplatin, leucovorin calcium, and fluorouracil
           with vs without cetuximab.

      Secondary

        -  Compare the 3-year disease-free survival rate and 5-year overall survival rate in
           patients treated with these regimens.

        -  Compare the overall survival of patients treated with these regimens.

        -  Compare the treatment compliance of patients treated with these regimens.

        -  Determine the prognostic factors and markers predictive for relapse and/or treatment
           efficacy in patients treated with these regimens.

        -  Compare the safety of these regimens in these patients.

      OUTLINE: This is an open-label, randomized, controlled, multicenter study. Patients are
      stratified according to obstruction/perforation status (no obstruction and no perforation vs
      obstruction and/or perforation), N stage (N1 vs N2), and T stage (T1-3 vs T4). Patients are
      randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium IV
           over 2 hours and fluorouracil IV continuously over 22 hours on days 1 and 2.

        -  Arm II: Patients receive chemotherapy as in arm I plus cetuximab IV over 1-2 hours on
           days 1 and 8.

      In both arms, treatment repeats every 14 days for up to 12 courses in the absence of disease
      progression or unacceptable toxicity.

      After completion of study treatment, patients are followed periodically for approximately 5
      years.

      PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.
    

Intervention name(s): Folfox; Cetuximab
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cetuximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III colon cancer; adenocarcinoma of the colon