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.