Randomized Double-blinded, Placebo-controlled Phase II Trial of Simvastatin and Gemcitabine in Advanced Pancreatic Cancer Patients
Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients
Sponsors
Source
Samsung Medical Center
Oversight Info
Has Dmc
No
Brief Summary
The purpose of this study is to determine whether simvastatin is effective in the treatment
of advanced pancreatic cancer patients.
Detailed Description
Randomized double-blinded, placebo-controlled phase II trial of simvastatin and gemcitabine
in advanced pancreatic cancer patients.
Overall Status
Completed
Start Date
2008-10-01
Completion Date
2014-02-01
Primary Completion Date
2013-09-01
Phase
Phase 2
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Time to progression |
Every 2 cycles until progression |
Secondary Outcome
Measure |
Time Frame |
|
Safety profiles of gemcitabine/simvastatin |
Every cycle until progression |
|
Response rate |
Every 2 cycles until progression |
|
Duration of response |
Every 2 cycles until progression |
|
Overall survival |
Every 3 months |
|
Correlative analyses |
after completion of accrual |
Enrollment
106
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
Gemcitabine and simvastatin
Arm Group Label
Gemcitabine+simvastatin
Other Name
Gemcitabine and simvastatin
Intervention Type
Drug
Intervention Name
Description
Gemcitabine plus Placebo
Arm Group Label
Gemcitabine+Placebo
Other Name
Gemcitabine plus Placebo
Eligibility
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
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Young Suk Park, M.D.,Ph.D. |
Principal Investigator |
Samsung Medical Center, Seoul, Korea |
Location
Facility |
|
Samsung Medical Center Seoul Korea, Republic of |
Location Countries
Country
Korea, Republic of
Verification Date
2017-02-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Samsung Medical Center
Investigator Full Name
Young Suk Park
Investigator Title
professor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Gemcitabine
Simvastatin
Arm Group
Arm Group Label
Gemcitabine+simvastatin
Arm Group Type
Experimental
Description
Gemcitabine and simvastatin
Arm Group Label
Gemcitabine+Placebo
Arm Group Type
Placebo Comparator
Description
Gemcitabine plus Placebo
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)
Study First Submitted
July 21, 2009
Study First Submitted Qc
July 22, 2009
Study First Posted
July 23, 2009
Last Update Submitted
February 15, 2017
Last Update Submitted Qc
February 15, 2017
Last Update Posted
February 17, 2017
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.