metastaic colorectal cancer
Conditions
Interventions
TAS-102: 35mg/m2 given orally twice a day in a 28-day cycle, 2-week cycle of 5 days treatment followed by a 2-day rest period, and then a 14-day rest period Bevacizumab: 5mg/kg given intravenously in
Sponsors
Tokushima University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) patient who has histologically or cytologically confirmed colorectal adenocarcinoma 2) patient who has confirmed K-RAS status of colorectal cancer 3) patient who has no previous chemotherapeutic history for metastatic colorectal cancer 4) patient who has at least one measurable lesion in imaging study within 28 days before enrollment (not essential criteria) 5) patient who is 70 years or older, and considered to be intorelant to strong chemotherapeutic regimens 6) patient with an ECOG Performance Status of between 0 and 2 7) patient with ability to tolerate oral drug administration 8) patient who has adequate main organ functions in tests within 14 days before enrollment neutrophil count:>=1,500/mm3 platelet count:>=100,000/mm3 haemoglobin concentorarion:>=9.0g/dL serum total bilirubin level:<=1.5mg/dL serum AST and ALT levels:<=100U/L serum creatinine:<=1.5mg/dL 9) patient who has a life expectancy of at least 3 months 10) written informed consent got from the patient
Exclusion criteria
Exclusion criteria: 1) patient who has chemotherapeutic history for colorectal cancer 2) patient who has history of hemoptysis(>=25mL, fresh blood) 3) patient with other active malignancies 4) patient with symptomatic brain metastasis 5) patient with serious pleural effusion, ascites or pericardial effusion 6) patient with active infection 7) patient with interstitial pneumonia or lung fibrosis confirmed in imaging study 8) patient who has important clinical complications(symptomatic unstable ischemic heart disease, arrhythmia, acute myocardial infarction within 6 months, liver cirrhosis, renal failure, active gastrointestinal ulcer, ileus, uncontrolled diabetes, uncontrolled hypertension, etc.) 9) patient with non-healing wound or traumatic bone fracture 10) patient with bleeding disorders or current use of anticoagulant 11) patient with severe drug allergy 12) male patient hoping partner's pregnancy 13) patient who has at least either one of HIV antibody, HBs antigen, or HCV antibody 14) patient given a dicision of unsuitable for this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| relative dose intensity | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, progression free survival, response rate, disease control rate, frequency and grade of adverse events | — |
Countries
Japan
Contacts
Public ContactTetsuji Takayama
Institute of Biomedical Sciences, Tokushima University Graduate School Gastroenterology and Oncology
Outcome results
None listed