Unresectable colorectal cancer
Conditions
Interventions
FOLFOXIRI+Bevacizumab
Sponsors
Aichi Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histological proven colorectal cancer 2) Measurable lesions not required 3) ECOG performance status 0-2 4) without any prior chemotherapy, or with prior 5-FU, FOFLOX adjuvant therapy after 6 months of last administration 5) Adequate organ function 6) Expected >12 weeks survival 7) Written informed consent from patient 8) Age>20 or older
Exclusion criteria
Exclusion criteria: Symptomatic brain metastasis Sever wattery diarrhea Paralytic or mechanical bowel obstruction Confirmed or suspected infection Severe pulmonary disease (interstitial pneumonia, pulmonary fobrosis, severe emphysematous) Severe comorbidity (uncontrolable diabetes, heart failure with NYHA 3 or 4, renal failure, liver failure) Pregnant or possibly pregnant, and nursing women Sever neurologic disease Receiving atazanavir sulfate Past history of monoclonal antibody allergy Past history of 5-FU/LV allergy Past history of FOLFOX allergy Complication of cerebrovascular disease or symptoms within 1 year Any surgical treatments including skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks or aspiration biopsy within one week Administering antithrombotic drug within 10 days Need to administrate or having anti-platelets therapy (including Methotrexate aspirin and NSAIDS) Evidence of bleeding diathesis or coagulopathy Active gastrointestinal ulcer Current or previous (within the last 1 year) history of GI perforation Non healing fracture Clinically significant (i.e. active) cardiovascular disease, or past or current history (within the last 1 year) of myocardial infarction Other conditions not suitable for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| maximum tolerated dose | — |
Secondary
| Measure | Time frame |
|---|---|
| recommended dose, response rate, toxicity | — |
Countries
Japan
Contacts
Public ContactUra Takashi
Aichi Cancer Center Hospital Department of Clinical Oncology
Outcome results
None listed