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

Phase 3

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: cetuximab; Drug: Irinotecan

• Registration Number: NCT00063141
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Study First Submitted: 2003-06-20
• Study First Submitted QC: 2003-06-24
• Study First Posted: 2003-06-25
• Primary Completion: 2006-06
• Study Completion: 2007-10
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-08
• Last Update Posted: 2010-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1302

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	cetuximab	-
Arm A	Irinotecan	-
Arm B	Irinotecan	-

Primary Outcome Measures

Name	Time	Method
Overall Survival	Every 3 months after subject off-treatment

Secondary Outcome Measures

Name	Time	Method
Quality of Life	Q6 Weeks
Health Economics	Q3 Weeks
Progression Free Survival	Q6 Weeks
Response	Q6 Weeks
Duration of Response	Q6 Weeks
Time to Response	Q6 Weeks
Disease Control Rate	Q6 Weeks
Safety	Q3 Weeks

Trial Locations

Locations (1)

ImClone Investigational Site; 🇬🇧 Sutton, Surrey, United Kingdom