Study of Irinotecan and Cetuximab Versus Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Cancer

Completed · Phase 3

Conditions studied: Colorectal Cancer

In brief

The purpose of this study is to determine whether overall survival is prolonged in subjects with metastatic, epidermal growth factor receptor (EGFR)-positive colorectal cancer treated with cetuximab in combination with irinotecan compared with irinotecan alone as second-line therapy following treatment with a fluoropyrimidine and oxaliplatin based, non-irinotecan-containing regimen.

Key facts

Study ID

NCT00063141

Run by

Eli Lilly and Company

People needed

1302

Starts

2003-04-01

Expected to finish

2007-10-01

Last updated by the study team

2010-04-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• ImClone Investigational Site — Pine Bluff, Arkansas, United States
• ImClone Investigational Site — Bakersfield, California, United States
• ImClone Investigational Site — Berkeley, California, United States
• ImClone Investigational Site — Beverly Hills, California, United States
• ImClone Investigational Site — Corona, California, United States
• ImClone Investigational Site — Gilroy, California, United States
• ImClone Investigational Site — Greenbrae, California, United States
• ImClone Investigational Site — Long Beach, California, United States
• ImClone Investigational Site — Los Angeles, California, United States
• ImClone Investigational Site — Los Angeles, California, United States
• ImClone Investigational Site — Montebello, California, United States
• ImClone Investigational Site — Orange, California, United States
• ImClone Investigational Site — Palm Springs, California, United States
• ImClone Investigational Site — Rancho Mirage, California, United States
• ImClone Investigational Site — San Diego, California, United States
• ImClone Investigational Site — Stockton, California, United States
• ImClone Investigational Site — Vallejo, California, United States
• ImClone Investigational Site — Aurora, Colorado, United States
• ImClone Investigational Site — Denver, Colorado, United States
• ImClone Investigational Site — New Haven, Connecticut, United States
• ImClone Investigational Site — New London, Connecticut, United States
• ImClone Investigational Site — Norwich, Connecticut, United States
• ImClone Investigational Site — Stamford, Connecticut, United States
• ImClone Investigational Site — Fort Myers, Florida, United States
• ImClone Investigational Site — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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