Phase II study of S-1+CPT-11+Bevacizumab as second-line therapy in metastatic colorectal cancer which has prior therapy of S-1+L-OHP+Bevacizumab
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-UMIN000015098
- Lead Sponsor
- Gunma University Graduate School
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
1. History of serious drug hypersensitivity 2. Pregnant, lactating or women of child-bearing potential. Men who want get partner pregnant. 3. Active infections 4. 4. Serious complications 5. Peptic ulcers 6. Over grade 2 diarrhea 7. Massive pleural effusion or ascites 8. Mechanical bowel obstruction 9. Symptomatic peritoneum dissemination 10. Brain metastasis 11. Current or previous (within the last 6 months) history of GI perforation 12. Hemoptysis 13. Previous history of thromboembolism, cerebral infarction, pulmonary infarction, interstitial pneumonia 14. Evidence of bleeding diathesis or coagulopathy 15. Ongoing treatment with anticoagulant or aspirin (> 325mg/day) 16. Administering transfusion within 14 days 17. Other active malignancies 18. Administration contraindication of 5-FU(Capecitabine, TS-1) Oxaliplatin, CPT-11 and Bevacizumab 19. 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 Progression-free survival
- Secondary Outcome Measures
Name Time Method Response rate (RR) Time to treatment failure (TTF) Overall Survival (OS) Safety profile Relative dose intensity(RDI)