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
- Conditions
- Colorectal carcinoma
- Registration Number
- JPRN-jRCT2080220192
- Lead Sponsor
- Bristol-Myers K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 38
Inclusion Criteria
1. Diagnosis of histologically confirmed, metastatic colorectal carcinoma (CRC) that is surgically unresectable. 2. Immuno histochemical evidence of EGFR expression. 3. Patients who have documented progressive disease to irinotecan based chemotherapy. 4. Patients who have failed previous fluoropyrimidine based chemotherapies. 5. Patients who have failed previous oxaliplatin-based chemotherapies. 6. Presence of at least one unidimensionally measurable lesion (target lesion by RECIST criteria). 7. Performance Status : 0 - 2
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy: response rate, duration of observed response Safety: incidence rates and severity of observed adverse events
- Secondary Outcome Measures
Name Time Method