Phase II study of S-1 plus irinotecan combined with bevacizumab as 2nd-line chemotherapy in patients with unresectable colorectal cancer, who had previously received oxaliplatin-based chemotherapy.
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-UMIN000006307
- Lead Sponsor
- Kyushu Study group of Clinical Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 37
Not provided
1) Serious complication ( ex. interstitial pneumonitis, pulmonary fibrosis, renal failure, liver failure, poorly-controlled diabetes, poorly-controlled hypertension) 2) Symptomatic or asymptomatic but treated heart disease 3) Active infection.. 4) Pleural effusion, peritoneal fluid 5) History of serious drug hypersensitivity or a history of drug allergy 6) Active other malignancies. 7) History of mental disturbances or cerebrovascular attack, central nervous system disorder 8) Brain metastasis 9) Peptic ulcer, bleeding, intestinal obstruction, intestinal paralysis , gastrointestinal perforation 10) History of gastrointestinal perforation 11) Watery stools or grade 2 or more diarrhea 12) History of thromboembolism, cerebral infarction 13) Hemorrhagic diathesis, coagulation disorder 14) Requiring anti-thrombogenic therapy to prevent thrombosis 15) Requiring steroid drug 16) Receiving flucytosine, atazanavir sulfate 17) Pregnant or lactating woman 18) No birth-control 19) Treatment history of irinotecan 20) History of hemoptysis 21) Contraindication to S-1, CPT-11, bevacizumab 22) High-grade stricture 23) Not appropriate for the study at the physician's assessment
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 Overall Survival Time to Treatment Failure Safety Investigation of Nausea and vomiting Quality of life