Study of Cetuximab, Oxaliplatin, 5-FU/LV Versus Oxaliplatin, 5-FU/LV in Patients With Previously Treated Metastatic, EGFR-Positive Colorectal Cancer

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company; ImClone LLC
• Collaborator: Bristol-Myers Squibb
• Treatments: Cetuximab; Fluorouracil; Leucovorin; Oxaliplatin

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.