ECOG N0147: OXAL PLUS 5-FU/CF W/WO CETUXIMAB IN STAGE III COLON CANCERECOG N0

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a randomized Phase III trial of FOLFOX vs. FOLFOX plus Cetuximab in patients after curative resection with stage III colon cancer. This is an ECOG study that was activated in February 2004 as a more complex 6-arm study. The trial has since been trimmed down to the two arms that other research has shown to still have the likelihood to yield valuable information. Cetuximab (Erbitux, C225) is an active agent and has proven efficacious as a single agent and in combination with chemotherapy for patients with advanced recurrent colon cancer. It was approved for the treatment of colon cancer in February 2004. Cetuximab is a monoclonal antibody that targets and inhibits epidermal growth factor receptor (EGFr) that has been found to be over-expressed in more than 35% of all solid malignant tumors. The goals of the study include an evaluation of the effectiveness of FOLFOX + Cetuximab in preventing disease recurrence, a comparison of the side effects in the two groups of patients in the study, a comparison of the effects of treatment on quality of life (changes to daily routines and feelings of overall health), an evaluation of any interaction between lifestyle habits, medication use or dietary patterns and the molecular markers contained within the tumor and to study whether eating habits affect the chances of disease recurrence. Tissue and blood specimens will be obtained to search for markers for treatment response. The drug combinations being studied are oxaliplatin, 5-fluorouracil and leucovorin (standard of care) versus the same drugs plus Cetuximab.