advanced and recurrent colorectal cancer
Conditions
Interventions
UFT 300mg/m2/day and LV 50mg/body/day is administered orally for 21 days every 28 days. Bevacizumab 5mg/kg is administered intravenous injection on day 1,15.
Sponsors
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients with pathologically proven colorectal cancer(adenocarcinoma) 2)Patients with unrecectable advanced and recurrent colorectal cancer 3)Patients with confirmed target lesion 4)Patients with no prior chemotherapy 5)Patients with no prior radiotherapy 6)Patients of age =>75 7)Performance Status:0-2(ECOG) 8)Patients with not enforceable intensive chemotherapy 9)Patients with expected life for at 90 days 10)Sufficient organ functions i. neutrophils>=1,500/mm3 ii. platelets>=100,000/mm3 iii. hemoglobin>=9.0g/dL iv. total bilirubin<=1.5mg/dL v. AST/ALT<=100IU(or <=150IU if liver metastases were present) vi.serum creatinine<=1.5mg/dL 11)Capability of oral intake 12)Written informed consent
Exclusion criteria
Exclusion criteria: 1)Medical history of severe anaphylazis or allergia to any drug 2)Active double cancer 3)Serious infection 4)Uncontrolled hypertention 5)Severe complication 6)Massive pleural or abdominal effusion 8)Brain metastasis 9)Severe mental illness 10)Systemic administration of corticosteroids 11)Uric protein 2+ 12)Thrombosis , cerebral infraction , cardiac infraction , pulmonary infraction 13)Patients who underwent surgery within 4 weeks 14)Systemic administration of antiplatelet drug 15)Patients with known bleeding disorders or clotting disorder 16)Patients who are judged inappropriate for the entry into the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease-free survival Overall survival | — |
Countries
Japan
Contacts
Public ContactMasataka Ikeda Tsunekazu Mizushima
Osaka University Graduate School of Medicine Department of Surgery
Outcome results
None listed