pancreatic cancer
Conditions
Interventions
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,
Sponsors
University of Tokyo, Department of Gastroenterology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, disease control rate, overall survival, toxicity | — |
Countries
Japan
Contacts
Public ContactYousuke Nakai
University of Tokyo Department of Gastroenterology
Outcome results
None listed