Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients

Condition(s) targeted: Pancreatic Cancer

Intervention: Gemcitabine and simvastatin (Drug); Gemcitabine plus Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Samsung Medical Center

Official(s) and/or principal investigator(s):
Young Suk Park, M.D.,Ph.D., Principal Investigator, Affiliation: Samsung Medical Center, Seoul, Korea

Overall contact:
YoungSuk Park, M.D., Phone: 822-3410-3459, Email: psy27hmo@skku.edu

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

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Time to progression

Secondary outcome:

Safety profiles of gemcitabine/simvastatin

Response rate

Duration of response

Overall survival

Correlative analyses

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

YoungSuk Park, M.D., Phone: 822-3410-3459, Email: psy27hmo@skku.edu

Samsung Medical Center, Seoul, Korea, Republic of; Recruiting
Young Suk Park, M.D.,Ph.D, Phone: 82-2-3410-3459, Email: psy27hmo@skku.edu

Starting date: January 2009
Last updated: July 22, 2009