advanced and recurrent colorectal cancer
Conditions
Interventions
Bevacizumab 5mg/kg is administered intravenous injection on day 1,15. UFT 300mg/m2/day and LV 75mg/body/day is administered orally for 21 days every 28 days.
Sponsors
Tukuba cancer clinical trial group Shikoku gastrointestinal oncology study group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with pathologically proven colorectal cancer 2)Patients with confirmed target lesion 3)Patients with no prior chemotherapy 4)Patients with no prior radiotherapy 5)Patients of age=>75 6)Performance Status0-1(ECOG) 7)Patients with expected life for at 3 months 8)Sufficient organ functions WBC>=3000/mm3 and <=12000/mm3 Neutrophils>=1500/mm3 Hemoglobin>=9.0g/dl Platelets>=100000/mm3 AST/ALT<=100IU Total bilirubin<=1.5mg/dl Creatinine<=1.5mg/dl normal EKG 9)Written informed consent 10)Capability of oral intake
Exclusion criteria
Exclusion criteria: 1)Concurrent treatment with prohibited medications, including phenytoin 2)Administration contraindication of UFT, leucovorin and bevacizumab 3)Serious infection 4)HBsAg potitive 5)Active double cancer 6)Uncontrolled hypertention 7)Severe complications 8)Massive pleural or abdominal effusion 9)Patient with the diarrhea 10)Brain metastasis 11)Uric protein 2+ 12)Men of the fertility hope 13)Pregnant or lactating female at any time during study 14)Systemic administration of corticosteroids 15)Thrombosis , cerebral infraction , cardiac infraction , pulmonary infraction 16)Patients who underwent surgery within 4 weeks 17)Systemic administration of antiplatelet drug 18)Patients with known bleeding disorders or clotting disorder 19)Severe mental illness 20)Patients who are judged inappropriate for the entry into the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Overall survival Response rate | — |
Countries
Japan
Contacts
Public ContactTomohiro Nishina
National hospital organizaion shikoku cancer center Department of internal medicine
Outcome results
None listed