Colorectal Cancer
Conditions
Interventions
Oxaliplatin 130mg/m2 i.v. (day1) Bevaciumab 7.5mg/Kg i.v. (day1) Capecitabine X2,000mg/m2, p.o.(day1-14) to be repeated every 3 weeks
Sponsors
Kyushu Study group of Clinical Cancer
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Written informed consent 2.Appropriate for the study at the physician's assessment 3.Histologically confirmed adenocarcinoma of the colon or rectum. 4.No prior chemotherapy for the patients with unresectable or recurrent colorectal cancer 5.Prior adjuvant chemotherapy is allowed if it is completed at least 2 weeks before registration. 6.No prior radiotherapy for target lesion. 7.Aged 20<= years. 8.ECOG performance status of 0-2. 9.At least one measurable lesion based on the RECIST criterion. (within 28 days before registration) 10.Life expectancy at least 3 months. 11.Required baseline laboratory parameters (within 14 days before registration): WBC more than 3000 and WBC less than 12000/mm3 Neu more than 1,500/ mm3 Plt more than 100,000/ mm3 Hb more than 9.0g/dl T-Bil less than 2.0mg/dl AST,ALT within 2.5 times of normal limit of each hospital(in case of hepatic metastatic patients are within 5.0 times of normal limit ) Cre less than 1.5mg/dl Urinary protein less than grade1 (+1 or 0.15-1.0g/24h)
Exclusion criteria
Exclusion criteria: 1.Co-mobility, such as infection, heart failure, history of cardiac infarction, liver cirrhosis, viral hepatitis type B , jaundice, kidney failure, uncontrolled hypertension, diabetes, interstitial lung disease, lung fibrosis, pulmonary emphysema. 2.Coelomic fluid which need therapy( pleural effusion, abdominal dropsy, pericardial fluid) 3.History of the severe hypersensitivity 4.Active other malignancies. 5.History of mental disorder, central nerve disorder, cerebral vascular disorder. 6.Brain metastasis 7.Evidence of bleeding diathesis, intestinal paralysis , ileus, peptic ulcer, traumatic bone fracture 8.Watery stools or Grade 2 or more diarrhea 9.Surgical procedure within 4 weeks before registration (implantation of the central venous port within 1 week before registration.) 10.Requiring anti-thrombogenic therapy to prevent thrombosis 11.Requiring immunosuppressive drug or steroid drug 12.Pregnant or lactating woman 13.Not appropriate for the study at the physician's assessment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival Time to tretment failure Time to failure of strategy Overall survival Safety Quality of life | — |
Countries
Japan
Contacts
Public ContactKSCC
CLinical Research Support Center Kyushu KSCC
Outcome results
None listed