Unique ID issued by UMIN | UMIN000001615 |
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Receipt number | R000001918 |
Scientific Title | The efficacy and safety of gemcitabine / cisplatin combination therapy in patients with advanced refractory biliary tract cancer |
Date of disclosure of the study information | 2009/01/03 |
Last modified on | 2012/01/04 08:32:29 |
The efficacy and safety of gemcitabine / cisplatin combination therapy in patients with advanced refractory biliary tract cancer
Gemcitabine / cisplatin combination therapy for advanced refractory biliary tract cancer
The efficacy and safety of gemcitabine / cisplatin combination therapy in patients with advanced refractory biliary tract cancer
Gemcitabine / cisplatin combination therapy for advanced refractory biliary tract cancer
Japan |
Advanced biliary tract cancer refractory to gemcitabine and S-1
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To evaluate the efficacy and safety of gemcitabine / cisplatin combination therapy in patients with advanced biliary tract cancer refractory to gemcitabine and S-1.
Safety,Efficacy
Exploratory
Pragmatic
Phase II
response rate
Time to progression, Overall survival, Toxicity
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Gemcitabine 1,000mg/m2 is administered as a 30min intravenous infusion on day 1 and day 8. Cisplatin 23mg/m2 is administered as 120min intravenous infusion on day 1 and day 8. The cycle is repeated every 3 weeks until disease progression.
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 advanced biliary tract cancer refractory to gemcitabine and S-1.
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.
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
20
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 | Takashi Sasaki |
Faculty of Medicine, University of Tokyo
Department of Gastroenterology
7-3-1, Hongo, Bunkyo-ku, Tokyo
03-3815-5411
Faculty of Medicine, University of Tokyo
None
Self funding
NO
2009 | Year | 01 | Month | 03 | Day |
Published
Completed
2007 | Year | 03 | Month | 15 | Day |
2007 | Year | 03 | Month | 01 | Day |
2010 | Year | 02 | Month | 01 | Day |
2009 | Year | 01 | Month | 03 | Day |
2012 | Year | 01 | Month | 04 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001918
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