Phase II study of gemcitabine and oxaliplatin (GEMOX) in gemcitabine refractory advanced biliary tract cancer (JASPAC02)
- Conditions
- gemcitabine refractory advanced biliary tract cancer
- Registration Number
- JPRN-UMIN000003650
- Lead Sponsor
- Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
1) Prior history of chemotherapy with oxaliplatin 2) Grade >= 2 sensory neuropathy 3) Plumonary fibrosis or interstitial pneumonia 4) Uncontrollable watery diarrhea 5) NYHA III or IV cardiac function 6) Myocardial infarction within six months 7) Active bacterial or fungous infection 8) Uncontrollable diabetes millitus 9) Blood transfusion within two weeks 10) Other severe complications such as heart failure, renal failure, liver failure, peptic ulcer, intestinal paralysis, etc 11) Psychosis or severe mental disorder 12) Severe drug allergy 13) Simultaneous or metachronous (within 3 years) double cancers, with the exception of intramucosal tumor curable with local therapy 14) Pregnant or lactating women or women of childbearing potential and men who want to get partner pregnant 15) Patients requiring systemic steroids medication 16) Patients who can' t receive neither iodic drug nor gadolinium because of drug allergy 17) Inadequate physical condition, as diagnosed by primary physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate
- Secondary Outcome Measures
Name Time Method adverse events serious adverse events progression-free survival overall survival