A phase ll study of Capecitabine plus Bevacizumab therapy for advanced/recurrent colo-rectal cancer with difficulty on intensive chemotherapy (OGSG 1102)
- Conditions
- colo-rectal cancer
- Registration Number
- JPRN-UMIN000005209
- Lead Sponsor
- Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1) with symptoms due to brain metastatis 2) with uncontrolable diarrhea 3) with difficulty on oral intake due to intestinal paralysis or obstruction 4) with infections diseases or febrile condition 5) with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc) 6) with severe diseases (uncontrollable DM, heart failure severe than NYHA lll, renal failure, and/or hepatic failure) 7) pregnant and/or nursing women, or women who expect pregnancy 8) with metastatic meningitis, uncontrollable convulsion, and/or mental disorder 9) with a grade 3 neural disorder 10) with a condition intlerance to medicines in this regimen 11) with a history of grade 3 allergy against Capecitabine 12) with a history of some chemotherapy and/or therapy including a VEGF antagonist 13) with a history of embolism, brain infraction (except Lacuna infraction) or pulmonary infraction 14) under easy bleeding condition due to some diseases or medicines (except low dose aspirin) 15) with a history of thoracic surgery of abdominal surgery 28 days ago 16) with active wounds except reservoir surgery 17) with a history of bloody spit more than 2.5ml 18) any other patient whom the physician in charge of the study judges to be unsuitable
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(RECIST) Disease controle rate Overall survival Adverse effect