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)
- Conditions
- advanced/metastatic colorectal cancer
- Registration Number
- JPRN-UMIN000002761
- Lead Sponsor
- PO FMPC (Future Medicine Promoting Consortium)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 45
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Rate of toxicity profile Disease control rate Over all survival Progression free survival