A Study of Cetuximab in Patients Who Have Stage IV Colorectal Cancer

Inclusion Criteria: * Subjects must have signed an approved informed consent prior to any study procedures. * Subjects with histologically or pathologically confirmed metastatic colorectal cancer, which is EGFR-positive by IHC (may be based on archival samples) * Subjects with ECOG performance status 0, 1 or 2. * Subjects who have failed, either due to lack of efficacy or due to intolerance, all available chemotherapy for the treatment of metastatic colorectal cancer. * Subjects who have failed to meet eligibility criteria for any other existing cetuximab trial. * Subjects must have received at least two chemotherapy regimens for metastatic disease OR adjuvant therapy plus one chemotherapy regimen for metastatic disease, provided the subject progressed within 6 months of completing their adjuvant therapy. * Prior chemotherapy must have included all of the follow drugs: irinotecan, oxaliplatin, and a fluoropyrimidine. * Subjects adequately recovered from any recent surgery, radiation therapy or chemotherapy. * Subjects accessible for treatment and follow-up. Subjects enrolled in this trial must be treated at the participating center. * Subjects greater or equal to 18 years of age. * Women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks afterwards. Exclusion Criteria: * Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. * Women who are pregnant or breastfeeding. * Women with a positive pregnancy test on enrollment or prior to study drug administration. * Sexually active, fertile men not using adequate birth control. * Subjects with dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. * Subjects with a serious uncontrolled medical disorder that would impair the ability of the patient to receive protocol therapy. * Subjects with a history of uncontrolled angina, arrhythmias, congestive heart failure, or myocardial infarction within the previous 6 months. * Subjects with any concurrent malignancy other than non-melanoma skin cancer, or carcinoma in situ of the cervix. Subjects with a previous malignancy but without evidence of disease for \> 5 years will be allowed to enter the trial. * Subjects with any history of severe hypersensitivity reactions and/or anaphylaxis resulting from the administration of protein based therapeutic agents. * Subjects with inadequate hematologic function defined by an absolute neutrophil count (ANC) \<1,250/mm3, a platelet count \<75,000/mm3, and a hemoglobin level \<8 g/dL. * Subjects with inadequate hepatic function, defined by a total bilirubin level ³3 times the upper limit of normal (ULN) and an aspartate transaminase (AST) and alanine transaminase (ALT) levels \>5 x ULN. * Subjects with inadequate renal function defined by a serum creatinine level \>2.5 x ULN. * Prior cetuximab therapy, prior randomization on a study which includes cetuximab therapy in a treatment arm, or any other prior therapy that targets the EGFR pathway. * A history of prior therapy with a chimerized or murine monoclonal antibody. * Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study. * A history of cetuximab or therapy that targeted the EGFR receptor. * A history of prior anti-cancer murine monoclonal antibody therapy. * Additional concurrent chemotherapy or other investigational anticancer agents may not be administered to subjects on this study.