Multicenter Phase II study of combination therapy with S-1 plus Irinotecan plus Cetuximab (MetronomicIRIS/Cmab combination therapy) in patients with KRAS wild type unresectable colorectal cancer, who had previously received on fluoropyrimidine , oxaliplatin , irinotecan and bevacizumab. (KSCOG CR-06)
Phase 2
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-UMIN000012063
- Lead Sponsor
- Kurume University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1) With contraindicate S-1 2) Patients under treatment with flucytosine,phenytoin,warfarin potassium 3) Patients who is receiving Atazanavir Sulfate 4) Severe bone marrow suppression 5) Active infection and inflammation 6) Comorbidity or history of interstitial lung disease or pulmonary fibrosis 7) Massive pleural effusion or ascites 8) Watery stools or diarrhea 9) Severe complications 10) Simultaneous or metachronous double cancers 11) Pregnant or lactating women or women of childbearing potential 12) Other patients who are unfit for the study as determined by the attending physician
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 response rate Disease control rate Overall survival Safety Dose intensity