$0.00
Shopping Cart
Facebook-f Instagram
DONATE
Donate

Clinical Trial Record

Return to Clinical Trials

Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients

2008-10

2013-09

2014-02

106

Study Overview

Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients

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

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

  • Pancreatic Cancer
  • DRUG: Gemcitabine+simvastatin
  • DRUG: Gemcitabine+Placebo
  • 2008-07-065

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2009-07-21  

N/A  

2017-02-15  

2009-07-22  

N/A  

2017-02-17  

2009-07-23  

N/A  

2017-02  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
Double

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Gemcitabine+simvastatin

Gemcitabine and simvastatin

DRUG: Gemcitabine+simvastatin

  • Gemcitabine and simvastatin
PLACEBO_COMPARATOR: Gemcitabine+Placebo

Gemcitabine plus Placebo

DRUG: Gemcitabine+Placebo

  • Gemcitabine plus Placebo
Primary Outcome MeasuresMeasure DescriptionTime Frame
Time to progressionEvery 2 cycles until progression
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Safety profiles of gemcitabine/simvastatinEvery cycle until progression
Response rateEvery 2 cycles until progression
Duration of responseEvery 2 cycles until progression
Overall survivalEvery 3 months
Correlative analysesafter completion of accrual

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Young Suk Park, M.D.,Ph.D., Samsung Medical Center, Seoul, Korea

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

    NPCF Pop up

    Make-A-Will Month

    Snag 6508be92
    Learn More
    Donate Now Online
    Other Ways to Donate