Unresectable and recurrent biliary tract cancer
Conditions
Interventions
CPT-11 60mg/m2 is administered as intravenous infusion 30min on day1, day8. S-1(60mg/m2) is given oral for 14 days followed by a week rest.The cycle is repeated every 3 weeks until disease progression
Sponsors
Yokohama City University Department of Gastroenterological Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with non-resectable or post-operative recurrent biliary tract cancer including intrahepatic cholangiocarcinoma 2) Patients with pathologically proven or graphically confirmed biliary tract cancer 3) Patients with advanced biliary tract cancer refractory to gemcitabine. 4) Patients with Eastern Chemotherapy Oncology Group(ECOG) performance status of 0-2 5) Patients of age >= 20 years 6) 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, AST and ALT <= 5 times the upper limit of normal, creatinine <= 1.5 times the upper limit of normal, and creatinine clearance >= 50ml/min. 7) 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 |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events serious adverse events progression-free survival overall survival | — |
Countries
Japan
Outcome results
None listed