Locally advanced or metastatic biliary tract cancer
Conditions
Interventions
Gemcitabine/CDDP/S-1 combination chemotherapy is conducted. CDDP (25mg/m2) and Gemcitabine (1000mg/m2) are administered intravenously at day 1 and 8. S-1 is orally administered twice daily at dose lev
Sponsors
Keio University, School of Medicine, Div. of Gastroenterology, Dept.of Internal Medicine
Kanagawa Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 biliary tract cancer confirmed adenocarcinoma or squamous cell cancer (intrahepatic bile duct cancer, extrahepatic bile duct cancer, gallbladder cancer, papilla cancer) 2 in operable advanced biliary tract cancer (include locally advanced or recurence) The presence or absence of measurable lesion does not matter. The patient with the measurable lesion conducting an examination for image within 28 days before registration. 3 with no prior therapy except for resection Patient who underwent adjuvant chemotherapy could be registered, if recurrence is confirmed more than 24 weeks from last administration day. 4 age 20 to 80 at registration 5 PS 0-1 6 sufficient function of important organs WBC: >=3,500/mm3 and <=12,000/mm3 Neu:>=2,000/mm3 Platelet: >=100,000/mm3 Hem: >=10.0g/dl GOT(AST): <= 100IU/l(or 150U/L if biliary drainage were present) GPT(ALT): <= 100IU/l(or 150U/L if biliary drainage were present) sT.bil: <=2.0mg/dl(or 3.0mg/dl if biliary drainage were present) serum Cr: =< 1.2mg/dL Ccr:>=60 ml/min/body 7 oral intake 8 clinically no abnormal findings to become the problem with an electrocardiogram within 28 days before registration 9 written informed consent
Exclusion criteria
Exclusion criteria: 1 biliary tract cancer confirmed adenocarcinoma or squamous cell cancer (intrahepatic bile duct cancer, extrahepatic bile duct cancer, gallbladder cancer, papilla cancer) 2 in operable advanced biliary tract cancer (include locally advanced or recurence) The presence or absence of measurable lesion does not matter. The patient with the measurable lesion conducting an examination for image within 28 days before registration. 3 with no prior therapy except for resection Patient who underwent adjuvant chemotherapy could be registered, if recurrence is confirmed more than 24 weeks from last administration day. 4 age 20 to 80 at registration 5 PS 0-1 6 sufficient function of important organs WBC: >=3,500/mm3 and <=12,000/mm3 Neu:>=2,000/mm3 Platelet: >=100,000/mm3 Hem:>=10.0g/dl GOT(AST): <= 100IU/l(or 150U/L if biliary drainage were present) GPT(ALT): <= 100IU/l(or 150U/L if biliary drainage were present) sT.bil: <=2.0mg/dl(or 3.0mg/dl if biliary drainage were present) serum Cr: =< 1.2mg/dL Ccr:>=60 ml/min/body 7 oral intake 8 clinically no abnormal findings to become the problem with an electrocardiogram within 28 days before registration 9 written informed consent 10 with interstitial pneumonia and lungs fiber syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PhaseI estimate the maximum tolerated dose(MTD)and recommended dose(RD)of Gemcitabine/CDDP/S-1 PhaseII Progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| PhaseI Adverse events, pharmacokinetics PhaseII Overall survival, Response Rate, Adverse events | — |
Countries
Japan
Contacts
Public ContactYasuo Hamamoto
Keio University, school of medicine Div. of Gastroenterology, Dept. of Internal Medicine
Outcome results
None listed