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