Phase I study of FOLFOXIRI+Bev for unresectabl colorecatal cancer
- Conditions
- nresectable colorectal cancer
- Registration Number
- JPRN-UMIN000010442
- Lead Sponsor
- Aichi Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 20
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method maximum tolerated dose
- Secondary Outcome Measures
Name Time Method recommended dose, response rate, toxicity