Colorectal Cancer
Conditions
Interventions
Oxaliplatin 130mg/m2 i.v. (day1) Bevaciumab 7.5mg/Kg i.v. (day1) Capecitabine2,000mg/m2,p.o.(day1-14) to be repeated every 3 weeks
Sponsors
Fukuoka Tumor Research(FUTURE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed colorectal cancer 2.Unresectable synchronous liver metastases 3.Resection of primary colorectal cancer 4.No prior chemotherapy and radiotherapy for colorectal cancer 5.Performance Status: 0-1 (ECOG criteria) 6.Age: 20 years to 75 years 7.Vital organ functions are preserved within 7 days prior to entry WBC :>= 3,000 and =< 12,000/mm3 Neutrophil : >=1,500/mm3 Platelet : >= 100,000/mm3 T.bil.: <= 2.0 mg/dl AST,ALT : <=100IU/l(in case of hepatic metastatic patients are <= 200IU/l) Creatinin : <= 1.35mg/dl(female),1.80mg/dl(male) 8.Signed written informed consent
Exclusion criteria
Exclusion criteria: 1.Prior severe drug allergy 2.Cavity fluid which needs drainage 3.Presence of active infection 4.Symptomatic brain metastases 5.Multiple malignancy within 5 years disease free interval 6.Uncontrolled hypertension 7.Uncontrolled diabetes 8.Peripheral nerve disorder 9.Severe pulmonary disease 10.Significant electrocardiographic abnormality 11.Treatment with anti-platelet drug 12.Chronic systemic treatment of corticosteroid 13.Nursing or pregnant females, or females or males with female partners who are planning to pregnancy 14.Inadequate for study enrollment by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate Time to treatment failure Overall survival Progression free survival Safety | — |
Countries
Japan
Contacts
Public ContactYoichiro Yoshida
Fukuoka University School of Medicine Gastroenterological Surgery
Outcome results
None listed