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.