A Phase 3 Randomized Multicenter Study of Cetuximab, Oxaliplatin, 5-Fluorouracil, and Leucovorin vs. Oxaliplatin, 5-Fluorouracil, and Leucovorin in Subjects With Previously Treated Metastatic, EGFR-Positive Colorectal Carcinoma

Inclusion Criteria:

- Documented colorectal cancer which is EGFR-positive and is metastatic.

- Prior irinotecan, alone or in combination, as first-line treatment of metastatic
disease.

Exclusion Criteria:

- A serious uncontrolled medical disorder that, in the opinion of the Investigator,
would impair the ability of the subject to receive protocol therapy.

- Known dihydropyrimidine dehydrogenase (DPD) deficiency.

- Known metastases in the central nervous system.

- Symptomatic sensory or peripheral neuropathy.

- More than one prior chemotherapy regimen for the treatment of metastatic colorectal
cancer.

- Prior oxaliplatin therapy.

- Prior cetuximab or other therapy which targets the EGF pathway.

- Prior chimerized or murine monoclonal antibody therapy.