WJOG6510G : Randomized phase II study of panitumumab + irinotecan versus cetuximab + irinotecan in Patients Wild-Type KRAS Metastatic Colorectal Cancer Following Treatment with Fluoropyrimidine, Irinotecan, and Oxaliplatin Chemotherapy
- Conditions
- advanced colorectal cancer
- Registration Number
- JPRN-UMIN000006643
- Lead Sponsor
- West Japan Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 120
Not provided
1) previous history of chemotherapy including cetuximab, or panitumumab 2) Final dose of prior CPT-11 <100mg/m2 3) having other active malignancies 4) severe complications (gastrointestinal bleeding, ileus, bowel obstruction, interstitial lung disease, pulmonary fibrosis, ischemic heart disease, arrhythmia, heart failure renal failure, hepatic failure, glaucoma, uncontrolled diabetes mellitus, etc.) 5) having active infections 6) uncontrollable diarrhea 7) moderate/severe pleural effusion or ascites 8) history of severe drug hypersensitivity 9) continuous steroid administration 10) Treatment with atazanavir sulfate 11) repeated gastrointestinal bleeding 12) uncontrollable seizures, serious mental problem 13) Symptomatic brain metastasis or meningitis carcinomatosis. 14) Pregnant or female intend to be pregnant, and male intend to make pregnant. 15) Others.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival
- Secondary Outcome Measures
Name Time Method Overall survival, response rate, disease control rate, safety,translational biomarker research