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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,302
Vial, IV, 400 mg/m² week 1 then 250 mg/m², weekly, until PD/Toxicity/Pt-PI Decision
Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision
Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision
Overall Survival
Time frame: Every 3 months after subject off-treatment
Progression Free Survival
Time frame: Q6 Weeks
Response
Time frame: Q6 Weeks
Duration of Response
Time frame: Q6 Weeks
Time to Response
Time frame: Q6 Weeks
Disease Control Rate
Time frame: Q6 Weeks
Safety
Time frame: Q3 Weeks
Quality of Life
Time frame: Q6 Weeks
Health Economics
Time frame: Q3 Weeks
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ImClone Investigational Site
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