Phase II study of S-1 plus irinotecan combined with biweekly cetuximab as 2nd-line chemotherapy in patients with wild type KRAS unresectable colorectal cancer, who had previously received oxaliplatin-based chemoterapy without CV port. (FUTURE 1103 STUDY)
Phase 2
Completed
- Conditions
- Colorectal Cancer
- Registration Number
- JPRN-UMIN000006823
- Lead Sponsor
- Fukuoka Tumor Research(FUTURE)
- 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) History of severe allergy 2) Simultaneous or metachronous double cancers 3) Symptomatic brain metastasis 4) Severe infectious disease 5) Severe complications (interstitial lung disease or pulmonary fibrosis, heart failure, kidney failure, hepatic failure, uncontrolable diabetes, Jaundice) 6) Paralytic or mechanical bowel obstruction 7) Massive pleural effusion or ascites 8) Wattery diarrhea 9) Patients who is receiving Atazanavir Sulfate or Flucytosine 10) Pregnant or lactating women or women of childbearing potential 11) Any other cases who are regarded as inadequate for study enrollment by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method Disease control rate Progression free survival Overall survival Safety