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
Phase 2
20 Years
75 Years
20 Years
75 Years
Not Enrolling
Both
Colorectal Carcinoma
Both
Colorectal Carcinoma
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response according to the RECIST criteria accessed every 6 weeks
Principal Investigator
Taku Seriu, MD
Investigator Role:
Study Director
Investigator Affiliation:
Bristol Myers K.K.
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
CA225-259
NCT ID:
NCT00362102
Start Date:
October 2005
Completion Date:
July 2006
Related Keywords:
- Colorectal Carcinoma
- EGFR-detectable metastatic colorectal carcinoma with documented progressive disease to irinotecan-based chemotherapy and failure
- Carcinoma
- Colorectal Neoplasms
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