Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients

Samsung Medical Center

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Drug: Gemcitabine+simvastatin; Drug: Gemcitabine+Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00944463

2008-07-065

Details and patient eligibility

About

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

Full description

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

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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106 participants in 2 patient groups, including a placebo group

Gemcitabine+simvastatin

Experimental group

Description:

Gemcitabine and simvastatin

Treatment:

Drug: Gemcitabine+simvastatin

Gemcitabine+Placebo

Placebo Comparator group

Description:

Gemcitabine plus Placebo

Treatment:

Drug: Gemcitabine+Placebo