This trial is active, not recruiting.

Condition pancreatic cancer
Treatments gemcitabine+simvastatin, gemcitabine+placebo
Phase phase 2
Sponsor Samsung Medical Center
Start date October 2008
End date September 2013
Trial size 115 participants
Trial identifier NCT00944463, 2008-07-065


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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Gemcitabine and simvastatin
gemcitabine+simvastatin Gemcitabine and simvastatin
Gemcitabine and simvastatin
(Placebo Comparator)
Gemcitabine plus Placebo
gemcitabine+placebo Gemcitabine plus Placebo
Gemcitabine plus Placebo

Primary Outcomes

Time to progression
time frame: Every 2 cycles until progression

Secondary Outcomes

Safety profiles of gemcitabine/simvastatin
time frame: Every cycle until progression
Response rate
time frame: Every 2 cycles until progression
Duration of response
time frame: Every 2 cycles until progression
Overall survival
time frame: Every 3 months
Correlative analyses
time frame: after completion of accrual

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Randomized Double-blinded, Placebo-controlled Phase II Trial of Simvastatin and Gemcitabine in Advanced Pancreatic Cancer Patients
Principal investigator Young Suk Park, M.D.,Ph.D.
Description Randomized double-blinded, placebo-controlled phase II trial of simvastatin and gemcitabine in advanced pancreatic cancer patients.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by Samsung Medical Center.