Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gemcitabine+simvastatin
Gemcitabine+Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring advanced pancreatic cancer, gemcitabine, simvastatin, placebo
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years
- 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)
- ECOG performance status of 0~2
- no radiotherapy within 1 month of the study entry
- measurable or evaluable lesion according to RECIST criteria
- no prior history of chemotherapy for pancreatic cancer (gemcitabine-based adjuvant chemotherapy ≥ 12 months from the study entry will be allowed)
- 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
- written informed consent must be provided
Exclusion Criteria:
- severe co-morbid illness and/or active infections
- pregnant or lactating women
- 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
- known history of hypersensitivity to study drugs
- patients who are currently on statin therapy or has taken statin as lipid lowering agents within 1 year of the study entry
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Gemcitabine+simvastatin
Gemcitabine+Placebo
Arm Description
Gemcitabine and simvastatin
Gemcitabine plus Placebo
Outcomes
Primary Outcome Measures
Time to progression
Secondary Outcome Measures
Safety profiles of gemcitabine/simvastatin
Response rate
Duration of response
Overall survival
Correlative analyses
Full Information
NCT ID
NCT00944463
First Posted
July 21, 2009
Last Updated
February 15, 2017
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00944463
Brief Title
Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients
Official Title
Randomized Double-blinded, Placebo-controlled Phase II Trial of Simvastatin and Gemcitabine in Advanced Pancreatic Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2008 (Actual)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
advanced pancreatic cancer, gemcitabine, simvastatin, placebo
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gemcitabine+simvastatin
Arm Type
Experimental
Arm Description
Gemcitabine and simvastatin
Arm Title
Gemcitabine+Placebo
Arm Type
Placebo Comparator
Arm Description
Gemcitabine plus Placebo
Intervention Type
Drug
Intervention Name(s)
Gemcitabine+simvastatin
Other Intervention Name(s)
Gemcitabine and simvastatin
Intervention Description
Gemcitabine and simvastatin
Intervention Type
Drug
Intervention Name(s)
Gemcitabine+Placebo
Other Intervention Name(s)
Gemcitabine plus Placebo
Intervention Description
Gemcitabine plus Placebo
Primary Outcome Measure Information:
Title
Time to progression
Time Frame
Every 2 cycles until progression
Secondary Outcome Measure Information:
Title
Safety profiles of gemcitabine/simvastatin
Time Frame
Every cycle until progression
Title
Response rate
Time Frame
Every 2 cycles until progression
Title
Duration of response
Time Frame
Every 2 cycles until progression
Title
Overall survival
Time Frame
Every 3 months
Title
Correlative analyses
Time Frame
after completion of accrual
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years
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)
ECOG performance status of 0~2
no radiotherapy within 1 month of the study entry
measurable or evaluable lesion according to RECIST criteria
no prior history of chemotherapy for pancreatic cancer (gemcitabine-based adjuvant chemotherapy ≥ 12 months from the study entry will be allowed)
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
written informed consent must be provided
Exclusion Criteria:
severe co-morbid illness and/or active infections
pregnant or lactating women
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
known history of hypersensitivity to study drugs
patients who are currently on statin therapy or has taken statin as lipid lowering agents within 1 year of the study entry
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young Suk Park, M.D.,Ph.D.
Organizational Affiliation
Samsung Medical Center, Seoul, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients
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