Unique ID issued by UMIN | UMIN000000590 |
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Receipt number | R000000716 |
Scientific Title | The efficacy and the safety of gemcitabine / S-1 combination therapy in patients with advanced non-resectable or post-operative recurrent biliary tract cancer -multicenter phase II study |
Date of disclosure of the study information | 2007/02/01 |
Last modified on | 2010/01/03 11:17:48 |
The efficacy and the safety of gemcitabine / S-1 combination therapy in patients with advanced non-resectable or post-operative recurrent biliary tract cancer -multicenter phase II study
Phase II study of gemcitabine / S-1 combination therapy in patients with advanced biliary tract cancer
The efficacy and the safety of gemcitabine / S-1 combination therapy in patients with advanced non-resectable or post-operative recurrent biliary tract cancer -multicenter phase II study
Phase II study of gemcitabine / S-1 combination therapy in patients with advanced biliary tract cancer
Japan |
Non-resectable or post-operative recurrent biliary tract cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
The purpose of this study is to evaluate the efficacy and the safety of gemcitabine / S-1 combination therapy in patients with non-resectable or post-operative recurrent biliary tract cancer
Safety,Efficacy
Exploratory
Explanatory
Phase II
Anti-tumor effect(Response rate, Disease control rate)
Safety
Progression-free survival, Overall survival, Drug administration compliance(Drug intensity, Drug feasibility)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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 is repeated every 4 weeks until evidence of disease progression, patient refusal or unacceptable toxicity.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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
35
1st name | |
Middle name | |
Last name | Hiroyuki Isayama |
Faculty of Medicine, University of Tokyo
Department of Gastroenterology
7-3-1 Hongo, Bunkyo-ku, Tokyo
03-3815-5411
1st name | |
Middle name | |
Last name | Hiroyuki Isayama |
Faculty of Medicine, University of Tokyo
Department of Gastroenterology
7-3-1 Hongo, Bunkyo-ku, Tokyo
03-3815-5411
isayama-2im@h.u-tokyo.ac.jp
Faculty of Medicine, University of Tokyo
None
Self funding
NO
2007 | Year | 02 | Month | 01 | Day |
Published
http://www.ncbi.nlm.nih.gov/pubmed/19707761?itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum&ordinalpos=3
Completed
2006 | Year | 12 | Month | 06 | Day |
2006 | Year | 12 | Month | 01 | Day |
2009 | Year | 01 | Month | 01 | Day |
2007 | Year | 02 | Month | 01 | Day |
2010 | Year | 01 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000716
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