Pancreatic Cancer
Conditions
Keywords
advanced pancreatic cancer, gemcitabine, simvastatin, placebo
Brief summary
The purpose of this study is to determine whether simvastatin is effective in the treatment of advanced pancreatic cancer patients.
Detailed description
Randomized double-blinded, placebo-controlled phase II trial of simvastatin and gemcitabine in advanced pancreatic cancer patients.
Interventions
DRUGGemcitabine+simvastatin
Gemcitabine and simvastatin
DRUGGemcitabine+Placebo
Gemcitabine plus Placebo
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to progression | Every 2 cycles until progression |
Secondary
| Measure | 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 |
Countries
South Korea
Outcome results
None listed