A Phase II Study of Cetuximab Plus Irinotecan in Patients With EGFR-detectable Metastatic Colorectal Carcinoma
Phase 2
Completed
- Conditions
- Colorectal Carcinoma
- Registration Number
- NCT00362102
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Response according to the RECIST criteria accessed every 6 weeks
- Secondary Outcome Measures
Name Time Method Time to progression, duration of achieved response, and the disease control rate will be accessed in all patients who received Cetuximab. The worst toxicity grades per patients will be tabulated for adverse events and laboratory measurements.