Colorectal Cancer
Conditions
Interventions
TAS-102 plus bevacizumab combination therapy (q4w) TAS-102: 35mg/m2 BID on days 1-5 and 8-12 Bevacizumab: 5mg/kg on day1 and 15
Sponsors
Osaka medical Center for Cancer and Cardiovascular Diseases
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) histologically proven colon cancer or rectal cancer (both Kras Wt and MT) 2) Group E : >= 76 years old Group ID : >= 65 years old and with difficulty on intensive chemotherapy due to history of radiation therapy for the pelvic lesions, s-albumin lower than 3.5g/dl and/or doctors decision not to register to the other chemotherapy from intolerance to adverse events 3) with mesurable lesions for RECIST criteria 4) without any chemotherapy berore (eligible if fluoro-pyrimidine treatment has completed more than 6 months before) 5) An Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 6) rest period from former therapy a) more than 4 weeks from an organ resection surgery b) more than 4 weeks from hormone therapy or immune therapy c) more than 4 weeks from cytokine or BRM therapy d) more than 6 weeks from radiation therapy for extensive lesions 7) without any severe complications and limited in the following data a) neutrophile : 1,500/mm3 <= b) platelet : 100,000/mm3 <= c) hemoglobin : 9.0g/dl <= d) T.bil. : 1.5mg/dl >= e) AST, ALT : 100 IU/l ( within 2.5 times of normal range of the hospital f) creatinine : 1.5mg/dl >= g) urine protein : 1+ >= h) PT-INR : 1.5 >= 8) patients expected more than 8 weeks survival 9) able to oral intake 10) written with informed consent
Exclusion criteria
Exclusion criteria: 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 condition intolerance to medicines in this regimen 10)with a history of some chemotherapy and/or therapy including a VEGF antagonist 11) with a history of embolism, brain infraction (except Lacuna infraction) or pulmonary infraction 12) under easy bleeding condition due to some diseases or medicines (except low dose aspirin) 13) with active wounds except reservoir surgery 14) with a history of bloody spit more than 2.5ml 15) with no bowel obstruction 16) with no peritoneum disseimination 17) any other patient whom the physician in charge of the study judges to be unsuitabl
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response Rate Disease control rate Overall survival Adverse events | — |
Countries
Japan
Contacts
Public ContactNaotoshi Sugimoto
Osaka medical Center for Cancer and Cardiovascular Diseases Clinical Oncology
Outcome results
None listed