Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients
NCT ID: NCT00944463
Last Updated: 2017-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
106 participants
INTERVENTIONAL
2008-10-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Gemcitabine+simvastatin
Gemcitabine and simvastatin
Gemcitabine+simvastatin
Gemcitabine and simvastatin
Gemcitabine+Placebo
Gemcitabine plus Placebo
Gemcitabine+Placebo
Gemcitabine plus Placebo
Interventions
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Gemcitabine+simvastatin
Gemcitabine and simvastatin
Gemcitabine+Placebo
Gemcitabine plus Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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)
3. ECOG performance status of 0\~2
4. no radiotherapy within 1 month of the study entry
5. measurable or evaluable lesion according to RECIST criteria
6. no prior history of chemotherapy for pancreatic cancer (gemcitabine-based adjuvant chemotherapy ≥ 12 months from the study entry will be allowed)
7. 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
8. written informed consent must be provided
Exclusion Criteria
2. pregnant or lactating women
3. 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
4. known history of hypersensitivity to study drugs
5. patients who are currently on statin therapy or has taken statin as lipid lowering agents within 1 year of the study entry
18 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Young Suk Park
professor
Principal Investigators
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Young Suk Park, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center, Seoul, Korea
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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2008-07-065
Identifier Type: -
Identifier Source: org_study_id
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