Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Young Suk Park, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00944463
First received: July 21, 2009
Last updated: June 12, 2013
Last verified: June 2013
  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+simvastatin
Drug: Gemcitabine+Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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: 115
Study Start Date: October 2008
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Young Suk Park, professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00944463     History of Changes
Other Study ID Numbers: 2008-07-065
Study First Received: July 21, 2009
Last Updated: June 12, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by 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
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Hypolipidemic Agents
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents

ClinicalTrials.gov processed this record on July 22, 2014