A Phase II 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.