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

Lilly

Status and phase: Completed; Phase 2

Conditions: Colorectal Carcinoma

Treatments: Drug: Cetuximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00362102

CA225-259

Details and patient eligibility

About

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.

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)