gemcitabine refractory advanced biliary tract cancer
Conditions
Interventions
Gemcitabine (1,000mg/m2, div, over 100 minutes, day1), Oxaliplatin (100mg/m2, div, over 120 minutes, day1), every 2 weeks
Sponsors
Japan Adjuvant Study Group of Pancreatic Cancer (JASPAC)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed as biliary tract cancer which includes intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer 2) Recurrent or unrespectable biliary tract cancer 3) Histologically proven papillary adenocarcinoma, tubular adenocarcinoma, or adenosquamous carcinoma for extrahepatic cholangiocarcinoma, gallbladder cancer, and ampulla of vater cancer patients. Histologically proven adenocarcinoma for intrahepatic cholangiocarcinoma 4) Refractory to one prior gemcitabine based chemotherapy 5) No previous therapy against biliary tract cancer 6) No previous chemotherapy or radiotherapy against any other malignancies within 3 years 7) Measurable disease as defined by Revised RECIST guideline (version 1.1) 8) At least 2 weeks have passed after the prior therapy 9) ECOG PS of 0 or 1 10) At least eight-week life expectancy 11) Without CNS metastasis 12) Without moderate or more ascites/pleural effusion 13) Sufficient oral intake 14) Aged 20 to 79 years old 15) Adequate organ functions 16) Written informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events serious adverse events progression-free survival overall survival | — |
Countries
Japan
Contacts
Public ContactAkira Fukutomi
JASPAC02 Coordinating Office Shizuoka Cancer Center, Division of GI Oncology
Outcome results
None listed