Status:
COMPLETED
Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients
Lead Sponsor:
Samsung Medical Center
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether simvastatin is effective in the treatment of advanced pancreatic cancer patients.
Detailed Description
Randomized double-blinded, placebo-controlled phase II trial of simvastatin and gemcitabine in advanced pancreatic cancer patients.
Eligibility Criteria
Inclusion
- Age \> 18 years
- Histologically or cytologically confirmed, metastatic or unresectable pancreatic adenocarcinoma (if repeated biopsy (\>3) fails or if biopsy is not feasible, the inclusion of the patient will be determined by the central PI)
- ECOG performance status of 0\~2
- no radiotherapy within 1 month of the study entry
- measurable or evaluable lesion according to RECIST criteria
- no prior history of chemotherapy for pancreatic cancer (gemcitabine-based adjuvant chemotherapy ≥ 12 months from the study entry will be allowed)
- adequate marrow, hepatic, renal and cardiac functions (absolute neutrophil count ≥ 1.5 x 109/L; platelet count ≥ 75 x 109/L, serum creatinine ≤ 1.5 x ULN), serum aspartate aminotransferase/alanine aminotransferase ≤ 5 x ULN or ≤ 10 x ULN if liver abnormalities are due to underlying malignancy; total bilirubin ≤ 2.0 x ULN
- written informed consent must be provided
Exclusion
- severe co-morbid illness and/or active infections
- pregnant or lactating women
- active CNS metastases not controllable with radiotherapy or corticosteroids A.patients with symptoms suggestive of CNS metastases must undergo radiologic evaluation to rule out metastases B.patients with known, asymptomatic CNS lesions are permitted
- known history of hypersensitivity to study drugs
- patients who are currently on statin therapy or has taken statin as lipid lowering agents within 1 year of the study entry
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00944463
Start Date
October 1 2008
End Date
February 1 2014
Last Update
February 17 2017
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea