Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients
This study is currently recruiting participants.
Verified January 2012 by Samsung Medical Center
Sponsor:
Samsung Medical Center
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00944463
First received: July 21, 2009
Last updated: January 10, 2012
Last verified: January 2012
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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: | 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 May 19, 2013