Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients
Randomized Double-blinded, Placebo-controlled Phase II Trial of Simvastatin and Gemcitabine in Advanced Pancreatic Cancer Patients
| Sponsors |
Lead Sponsor: Samsung Medical Center |
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| Source | Samsung Medical Center | ||||||||||||
| Brief Summary | The purpose of this study is to determine whether simvastatin is effective in the treatment of advanced pancreatic cancer patients. |
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| Detailed Description | Randomized double-blinded, placebo-controlled phase II trial of simvastatin and gemcitabine in advanced pancreatic cancer patients. |
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| Overall Status | Completed | ||||||||||||
| Start Date | October 2008 | ||||||||||||
| Completion Date | February 2014 | ||||||||||||
| Primary Completion Date | September 2013 | ||||||||||||
| Phase | Phase 2 | ||||||||||||
| Study Type | Interventional | ||||||||||||
| Primary Outcome |
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| Secondary Outcome |
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| Enrollment | 106 | ||||||||||||
| Condition | |||||||||||||
| Intervention |
Intervention Type: Drug Intervention Name: Gemcitabine+simvastatin Description: Gemcitabine and simvastatin Arm Group Label: Gemcitabine+simvastatin Other Name: Gemcitabine and simvastatin Intervention Type: Drug Intervention Name: Gemcitabine+Placebo Description: Gemcitabine plus Placebo Arm Group Label: Gemcitabine+Placebo Other Name: Gemcitabine plus Placebo |
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| 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 |
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| Overall Official |
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| Location |
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| Location Countries |
Korea, Republic of |
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| Verification Date |
February 2017 |
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| Responsible Party |
Type: Principal Investigator Investigator Affiliation: Samsung Medical Center Investigator Full Name: Young Suk Park Investigator Title: professor |
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| Keywords | |||||||||||||
| Has Expanded Access | No | ||||||||||||
| Condition Browse | |||||||||||||
| Number Of Arms | 2 | ||||||||||||
| Arm Group |
Label: Gemcitabine+simvastatin Type: Experimental Description: Gemcitabine and simvastatin Label: Gemcitabine+Placebo Type: Placebo Comparator Description: Gemcitabine plus Placebo |
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| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Primary Purpose: Treatment Masking: Double (Participant, Investigator) |
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