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Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients
This study is currently recruiting participants.
Verified by Samsung Medical Center, July 2009
First Received: July 21, 2009   Last Updated: July 22, 2009   History of Changes
Sponsor: Samsung Medical Center
Information provided by: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00944463
  Purpose

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


Condition Intervention Phase
Pancreatic Cancer
Drug: Gemcitabine and simvastatin
Drug: Gemcitabine plus Placebo
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Randomized Double-blinded, Placebo-controlled Phase II Trial of Simvastatin and Gemcitabine in Advanced Pancreatic Cancer Patients

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Time to progression [ Time Frame: Every 2 cycles until progression ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety profiles of gemcitabine/simvastatin [ Time Frame: Every cycle until progression ] [ Designated as safety issue: Yes ]
  • Response rate [ Time Frame: Every 2 cycles until progression ] [ Designated as safety issue: Yes ]
  • Duration of response [ Time Frame: Every 2 cycles until progression ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]
  • Correlative analyses [ Time Frame: after completion of accrual ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2009
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Gemcitabine+simvastatin: Experimental
Gemcitabine and simvastatin
Drug: Gemcitabine and simvastatin
Gemcitabine and simvastatin
Gemcitabine+Placebo: Placebo Comparator
Gemcitabine plus Placebo
Drug: Gemcitabine plus Placebo
Gemcitabine plus Placebo

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944463

Contacts
Contact: YoungSuk Park, M.D. 822-3410-3459 psy27hmo@skku.edu
Contact: YangHee Kim, RN 822-3410-6483 juragee.kim@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Young Suk Park, M.D.,Ph.D     82-2-3410-3459     psy27hmo@skku.edu    
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Young Suk Park, M.D.,Ph.D. Samsung Medical Center, Seoul, Korea
  More Information

No publications provided

Responsible Party: Samsung Medical Center ( Young Suk Park M.D., Ph.D. )
Study ID Numbers: 2008-07-065
Study First Received: July 21, 2009
Last Updated: July 22, 2009
ClinicalTrials.gov Identifier: NCT00944463     History of Changes
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
advanced pancreatic cancer
gemcitabine
simvastatin
placebo

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

ClinicalTrials.gov processed this record on February 08, 2010