In This SectionTexas Health Research & Education Institute
Disease or Condition
Comparison of Combination Chemotherapy Regimens With or Without Cetuximab in Treating Patients Who Have Undergone Surgery For Stage III Colon Cancer
Drugs used in chemotherapy, such as fluorouracil, leucovorin, 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 is not yet known which combination chemotherapy regimen is more effective after surgery in treating colon cancer. This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well they work when given with or without cetuximab in treating patients who have undergone surgery for stage III colon cancer.
Patients diagnosed with Stage III adenocarcinoma of the colon with one or more positive lymph nodes.
Tumors must be completely resected with a gross inferior margin for the primary tumor =12 cm from the anal verge.
Patients with one or more synchronous primary colon cancer will be staged based on the more advanced tumor.
Patients with distant metastases at randomization.
Patients with prior treatment with agents directed against EGFR.
Patients with previous chemotherapy or radiation therapy for treatment of this malignancy and no concurrent use of chemotherapy, targeted or biological agents.
Patients with previous (within the last 5 years) or concurrent malignancy except for treated basal or squamous cell skin cancer, in situ cervical cancer or lobular carcinoma of the breast.
Patients with a history of myocardial infarction within 6 months.
Patients with a history of GI bleeding.
Patients with active uncontrolled bacterial, viral or systemic fungal infection, symptomatic CHF (NYHA Class III or IV), unstable angina, uncontrolled hypertension, pulmonary fibrosis or interstitial pneumonitis.
Patients with known hypersensitivity to platinum compounds, chimerized or murine monoclonal antibody therapy or documented presence of human anti-mouse antibodies.