JPRN-UMIN000002761RecruitingPhase 2
Phase II trial of irinotecan with biweekly cetuximab in unresectable advanced and/or metastatic colorectal cancer, evaluation of the safety and efficacy based on EGFR positive and KRAS wild type.(i-BEX trial) - Phase II trial of irinotecan with biweekly cetuximab in advanced and/or metastatic colorectal cancer.(i-BEX trial)
PO FMPC (Future Medicine Promoting Consortium)0 sites45 target enrollmentStarted: November 16, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 45
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1)history of severe allergy 2)severe complications paralytic or mechanical bowel obstruction interstitial lung disease pulmonary fibrosis heart failure liver failure renal insufficiency 3)Patients who had received at least cetuximab contained chemotherapy 4)Patients who are impossible to receive irinotecan contained chemotherapy severe infectious disease watery diarrhea massive pleural effusion or ascites Jaundice Patients who is receiving Atazanavir Sulfate 5)Pregnant or lactating women or women of childbearing potential 6)Symptomatic brain metastasis 7)Patients with active double cancer 8)Patients who are considered unfit for enrollment in the study because of mental illness, etc. of clinical relevance 9)Patients with heart disease of clinical relevance 10)Inadequate physical condition, as diagnosed by primary physician
Investigators
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