Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine whether simvastatin is effective in the treatment of advanced pancreatic cancer patients.

Detailed Description
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Randomized double-blinded, placebo-controlled phase II trial of simvastatin and gemcitabine in advanced pancreatic cancer patients.

Official Title
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Randomized Double-blinded, Placebo-controlled Phase II Trial of Simvastatin and Gemcitabine in Advanced Pancreatic Cancer Patients

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Gemcitabine+simvastatin
* Drug: Gemcitabine+Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine+simvastatin<br>Gemcitabine and simvastatin | Drug: Gemcitabine+simvastatin<br>* Gemcitabine and simvastatin<br>* Other names: Gemcitabine and simvastatin;|
| Placebo Comparator: Gemcitabine+Placebo<br>Gemcitabine plus Placebo | Drug: Gemcitabine+Placebo<br>* Gemcitabine plus Placebo<br>* Other names: Gemcitabine plus Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  | Every 2 cycles until progression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced pancreatic cancer, gemcitabine, simvastatin, placebo