Unique ID issued by UMIN | UMIN000005580 |
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Receipt number | R000006565 |
Scientific Title | A phase 2 study of combination therapy with gemcitabine and candesartan in patients with advanced or recurrent pancreatic cancer |
Date of disclosure of the study information | 2011/05/10 |
Last modified on | 2015/12/11 08:17:34 |
A phase 2 study of combination therapy with gemcitabine and candesartan in patients with advanced or recurrent pancreatic cancer
GECA-2 study
A phase 2 study of combination therapy with gemcitabine and candesartan in patients with advanced or recurrent pancreatic cancer
GECA-2 study
Japan |
pancreatic cancer
Hepato-biliary-pancreatic medicine |
Malignancy
NO
To evaluate the efficacy and safety of combination therapy with gemcitabine and candesartan in patients with advanced or recurrent pancreatic cancer.
Safety,Efficacy
Exploratory
Explanatory
Phase II
Time to progression
Response rate, disease control rate, overall survival, toxicity
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Candesartan 16 mg is administered orally qd daily and gemcitabine is administered 1,000 mg/m2 30min i.v. day 1, 8, 15, repeated every 4 weeks until disease progression. In patients with hypertension, candesartan is started at the dose of 8mg, then escalated to 16 mg from the 2nd course.
20 | years-old | <= |
Not applicable |
Male and Female
1) Patients with non-resectable or post-operative recurrent pancreatic cancer
2) Patients with pathologically proven or graphically confirmed pancreatic cancer
3) Patients with no prior therapy except surgery
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 <= the upper limit of normal, and potassium <= the upper limit of normal
7) Written informed consent is required from all patients.
1) Patients with systolic blood pressure < 100mmHg
2) Patients with an active concomitant infection
3) Patients with digestive ulcer or gastrointestinal bleeding
4) Patients with severe heart or renal disease
5) Patients with an active pulmonary fibrosis or interstitial pneumonia
6) Patients with a previous history of a severe drug hypersensitivity
7) Patients with an active concomitant malignancy
8) Pregnant, lactating female and patients of reproductive potential who did not use effective contraception
9) Patients with uncontrollable massive pleural effusion or massive ascites
10) Inappropriate patients for entry on this study in the judgement of the investigator
33
1st name | |
Middle name | |
Last name | Hiroyuki Isayama |
University of Tokyo
Department of Gastroenterology
7-3-1, Hongo, Bunkyo-ku, Tokyo, JAPAN 113-8655
1st name | |
Middle name | |
Last name | Yousuke Nakai |
University of Tokyo
Department of Gastroenterology
ynakai-tky@umin.ac.jp
University of Tokyo, Department of Gastroenterology
none
Self funding
NO
2011 | Year | 05 | Month | 10 | Day |
Published
http://link.springer.com/article/10.1007%2Fs10637-013-9972-5
Main results already published
2011 | Year | 05 | Month | 09 | Day |
2011 | Year | 05 | Month | 01 | Day |
2011 | Year | 05 | Month | 10 | Day |
2015 | Year | 12 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006565
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