Phase II study of bevacizumab and irinotecan plus alternate-day S-1 as second-line therapy in patients with metastatic colorectal cancer.
- Conditions
- Metastatic colorectal cancer.
- Registration Number
- JPRN-UMIN000008947
- Lead Sponsor
- Epidemiological and Clinical research Information Network (ECRIN)
- 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)Active infections 3) Serious complications (interstitial pneumonitis, pulmonary fibrosis, renal failure, liver dysfunction, poorly controlled DM, poorly controlled hypertension) 4) Distinctly abnormal ECG or cardiovascular disease (heart failure, myocardial infarction, angina) 5) Massive pleural effusion or ascites 6) Ongoing treatment with Flucytosine, Phenytoin or Warfarin potassium 7) Synchronous or metachronous malignancy except carcinoma in situ 8) Prior radiotherapy 9) Diarrhea 10) Active hepatitis type HBs positive 11) History of thromboembolism, brain infarction, pulmonary infarction and interstitial pneumonitis 12) GI perforation or hemorrhage 13) Peritoneal metastasis 14) Brain metastasis 15)Pregnant or possibly pregnant women 16) Men who want get partner pregnant. 17) Other conditions not suitable for this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of grade 3 or 4 diarrhea
- Secondary Outcome Measures
Name Time Method Response rate, Disease-cintrol rate, Overall survival, Progression-free survival, Time to treatment failure, Treatment completion rate, Safety