Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients - Full Text View

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+simvastatin Drug: Gemcitabine+Placebo	Phase II

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:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Simvastatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

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 Study Completion Date:	September 2012
Estimated Primary Completion Date:	April 2012 (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:

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

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:	Young Suk Park M.D., Ph.D., 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:	January 10, 2012
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 February 09, 2012