A Phase II Study of Cetuximab Plus Irinotecan in Patients With EGFR-detectable Metastatic Colorectal Carcinoma

A Multi-center, Open Label, Non-randomized, Phase II Study to Assess the Activity and Safety of Cetuximab Plus Irinotecan in Subjects With EGFR-detectable Metastatic Colorectal Carcinoma

To evaluate the response rate of cetuximab plus irinotecan combination therapy in subjects with EGFR-detectable metastatic colorectal carcinoma who have documented progressive disease to irinotecan-based chemotherapy and who have failed (progressive disease or intolerance) previous oxaliplatin-based and fluoropyrimidine-based chemotherapies.

Inclusion Criteria:

• The subject must have surgically unresectable metastatic colorectal carcinoma.
• The subjects who have received and failed Ilinotecan, oxaliplatin and fluoropyrimidine-based chemotherapy
• ECOG PS 0-2

Exclusion Criteria:

• Subjects with symptomatic cerebral metastasis