Revised Protocol 07 to Protocol CA225006 - A Phase III Randomized, Open-Label, Multicenter Study of Irinotecan and Cetuximab vs. Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Carcinoma

Inclusion Criteria:

- Histologically documented colorectal cancer which is EGFR-positive by
immunohistochemistry [IHC] (may be based on archival samples) and is metastatic.

- Prior oxaliplatin administered for the first-line treatment of metastatic colorectal
cancer.

- Prior fluoropyrimidine-containing regimen (5-fluorouracil [5-FU], capecitabine, or
uracil/tegafur [UFT]), for the 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

- Unresolved diarrhea, bowel obstruction, or history of inflammatory bowel disease

- Known or documented brain metastases