metastatic colorectal cancer
Conditions
Interventions
TAS-102: 35mg/m2 given orally twice daily on days 1-5 and 15-19 in a 28-day cycle. Bevacizumab: 5mg/kg given intravenously in a 2-week cycle
Sponsors
Department of Digestive Surgery,Nippon Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically proven colorectal cancer 2)patient who has unresectable primary tumor or with one or more unresectable metatatic tumor(s) 3)treatment history of two or more regimens for metastatic colorectal cancer, and who has confirmed PD in imaging study 4)20<= and 80>= years old 5)ECOG performance status of 0 or 1 6)With measurable lesions according 7)ability to tolerate oral drug administration 8)a life expectancy of at least 3 months 9)Patient who has adequate main organ functions in tests within 14 days beforeenrollment leukocyte >=3,500/mm3 neutrophil >=1,500/mm3 platelet >=75,000/mm3 haemoglobin concentorarion >=8.0 g/dL serum total bilirubin level <=1.5 mg/dLserum creatinine <=1.5 mg/dL serum AST and ALT levels <2.5x Upper limit of normal (ULN). serum creatinine <=1.5 mg/dL Peripheral neuropathy<=grade2 Diarrhea and NonHaematotoxicity =<grade1 10)gave written informed consent
Exclusion criteria
Exclusion criteria: 1)contraindications for TAS-102 and Bevacizumab 2)previously received chemotherapy with TAS-102 3)severe drug allergy 4)pregnant woman or Possibility of the pregnant woman. male patient who hoping partner's pregnancy. 5)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.) 6)other active malignancies 7)have pleural effusion and ascitic fluid with the treatment 8)Comorbidity or history of heart failure 9)gastrointestinal ulcer or bleeding 10)previous hemoptysis 11)Clinical or radiological evidence of CNS metastases 12)Current or previous (within the last 6 months) history of GI perforation 13)Patient with interstitial pneumonia or lung fibrosis confirmed in imaging study 14)ongoing treatment with anticoagulant 15)Synchronous or metachronous multiple malignancy within the last 5 year disease free interval 16)Under continuous steroid administration 17)decision of unsuitable for this study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate , overall survival, Safety, and incidence of Grade 3 neutropenia | — |
Countries
Japan
Contacts
Public ContactTakeshi Yamada
Nippon Medical School Digestive Surgery
Outcome results
None listed