Greenbrae,
California
94904
Purpose:
The purpose of this study is to compare overall survival in patients with previously-treated
metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with
oxaliplatin, 5-fluorouracil and leucovorin (FOLFOX4) and cetuximab with FOLFOX4 alone.
Criteria:
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.