Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone

Inclusion Criteria:

• Man or woman at least 18 years old
• Diagnosis of metastatic colorectal cancer
• One and only one chemotherapy regimen for mCRC consisting of first-line 5-FU -based chemotherapy
• Radiologically documented disease progression per modified RECIST criteria during treatment or within 6 months of last dose of first-line chemotherapy
• At least 1 uni-dimensionally measurable lesion of at least 20 mm per modified RECIST
• ECOG status of 0, 1, or 2
• Paraffin-embedded tumor tissue from the primary tumor or metastasis available for central analyses
• Adequate hematologic, renal, and hepatic functions
• Negative pregnancy test within 72 hours of enrollment
• Other protocol-specified criteria may apply

Exclusion Criteria:

• History of or known presence of CNS metastases
• History of another primary cancer within 5 years of randomization
• Prior irinotecan therapy
• Prior anti-EGFr antibody therapy or treatment with small molecule EGFr inhibitors
• Any investigational agent or therapy within 30 days before randomization
• Known allergy or hypersensitivity to irinotecan, 5-FU or leucovorin
• History of interstitial lung disease or evidence of interstitial lung disease on baseline chest CT scan
• Active inflammatory bowel disease or other bowel disease causing chronic diarrhea
• Known positive tests for HIV, HCV, acute or chronic active HBV
• Major surgery within 28 days of randomization or minor surgical procedure within 14 days of randomization
• Pregnant or breast-feeding
• Man or woman of child-bearing potential not consenting to use adequate contraceptive methods or abstinence during the course of the study and for 6 months after last study drug administration (women) or 1 month after last study drug administration (men)
• Other protocol-specified criteria may apply