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Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients

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ClinicalTrials.gov Identifier: NCT00944463
Recruitment Status : Completed
First Posted : July 23, 2009
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Young Suk Park, Samsung Medical Center

Brief Summary:
The purpose of this study is to determine whether simvastatin is effective in the treatment of advanced pancreatic cancer patients.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Gemcitabine+simvastatin Drug: Gemcitabine+Placebo Phase 2

Detailed Description:
Randomized double-blinded, placebo-controlled phase II trial of simvastatin and gemcitabine in advanced pancreatic cancer patients.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Double-blinded, Placebo-controlled Phase II Trial of Simvastatin and Gemcitabine in Advanced Pancreatic Cancer Patients
Actual Study Start Date : October 2008
Actual Primary Completion Date : September 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Gemcitabine+simvastatin
Gemcitabine and simvastatin
Drug: Gemcitabine+simvastatin
Gemcitabine and simvastatin
Other Name: Gemcitabine and simvastatin

Placebo Comparator: Gemcitabine+Placebo
Gemcitabine plus Placebo
Drug: Gemcitabine+Placebo
Gemcitabine plus Placebo
Other Name: Gemcitabine plus Placebo




Primary Outcome Measures :
  1. Time to progression [ Time Frame: Every 2 cycles until progression ]

Secondary Outcome Measures :
  1. Safety profiles of gemcitabine/simvastatin [ Time Frame: Every cycle until progression ]
  2. Response rate [ Time Frame: Every 2 cycles until progression ]
  3. Duration of response [ Time Frame: Every 2 cycles until progression ]
  4. Overall survival [ Time Frame: Every 3 months ]
  5. Correlative analyses [ Time Frame: after completion of accrual ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age > 18 years
  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:

  1. severe co-morbid illness and/or active infections
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00944463


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Young Suk Park, M.D.,Ph.D. Samsung Medical Center, Seoul, Korea

Responsible Party: Young Suk Park, professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00944463     History of Changes
Other Study ID Numbers: 2008-07-065
First Posted: July 23, 2009    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017

Keywords provided by Young Suk Park, Samsung Medical Center:
advanced pancreatic cancer
gemcitabine
simvastatin
placebo

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Simvastatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors