Non-resectable or post-operative recurrent biliary tract cancer
Conditions
Interventions
Gemcitabine 1,000mg/m2 is administered as a 30-min intravenous infusion on day 1 and day 15. S-1 40mg/m2 is administered orally twice a day from day 1 to day 14 followed by a two-week rest. The cycle
Sponsors
Faculty of Medicine, University of Tokyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with non-resectable or post-operative recurrent biliary tract cancer 2) Patients with pathologically proven or graphically confirmed biliary tract cancer 3) Patients with no prior therapy except surgery 4) Patients with one or more bidimentionally measurable lesions 5) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2 6) Patients of age >= 20 years 7) Patients have an adequate organ function defined as white cell count >= 3,000/mm3, platelet count >= 100,000/mm3, hemoglobin >= 9g/dl, total bilirubin <= 3 times the upper limit of normal, direct bilirubin <= 2 times the upper limit of normal, AST and ALT <= 5 times the upper limit of normal, creatinine <= 1.5 times the upper limit of normal, and creatinine clearance >= 50ml/min. 8) Patients have an ability for a sufficient oral intake 9) Written informed consent is required from all patients.
Exclusion criteria
Exclusion criteria: 1) Patients with an active concomitant infection 2) Patients with digestive ulcer or gastrointestinal bleeding 3) Patients with severe cardiovascular or renal disease 4) Patients with an active pulmonary fibrosis or interstitial pneumonia 5) Patients with uncontrollable massive pleural effusion or massive ascites 6) Patients with an active concomitant malignancy 7) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception 8) Patients with a previous history of a severe drug hypersensitivity 9) Patients receiving anti-cancer drugs 10) Inappropriate patients for entry on this study in the judgement of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-tumor effect(Response rate, Disease control rate) Safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival, Overall survival, Drug administration compliance(Drug intensity, Drug feasibility) | — |
Countries
Japan
Contacts
Public ContactHiroyuki Isayama
Faculty of Medicine, University of Tokyo Department of Gastroenterology
Outcome results
None listed