Patients with advanced biliary tract cancer that was not amenable to potentially curative surgery or that had recurred after surgery
Conditions
Interventions
S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeasted every 2 weeks.
Sponsors
Kansai Hepatobiliary Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with cytologically or histologically proved biliary tract cancer 2. age >=20 years 3. PS 0-2 4. No prior history of chemotherapy or radiotherapy. Patients who has undergone adjuvant chemotherapy are eligible if at least 6 months has passed since the last administration. 5. Adequate bone marrow function (neutrophil count >=1,500/mm3, and platelet count >=100,000/mm3), liver function (total bilirubin >=3 mg/dL and AST/ALT >=150 IU/L), and renal function (creatinine clearance >=60 mL/min) 6.No other serious comorbid disease 7.Adequate oral intake 8.Provided written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with interstitial pneumonia or pulmonary fibrosis 2. Patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months 3. Patients with severe active infection 4. Patients who are pregnant or lactating, or have an intention to get pregnant 5. Patients with a history of severe drug allergy 6. Patients with other serious comorbid disease 7. Patients with mental disease 8. Patients who are judged inappropriate for the entry into the study by the principle doctor 9. Patients with watery diarrhea
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I Safety Phase II Overall Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase II Toxicity and response rate | — |
Countries
Japan
Contacts
Public ContactMasashi Kanai
Kyoto University Hospital Department of Clinical Oncology and Pharmacogenomics
Outcome results
None listed