Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients

Phase 2

Completed

• Conditions: Pancreatic Cancer
• Interventions: Drug: Gemcitabine+simvastatin; Drug: Gemcitabine+Placebo

• Registration Number: NCT00944463
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-22
• Study First Posted: 2009-07-23
• Primary Completion: 2013-09
• Study Completion: 2014-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-15
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemcitabine+simvastatin	Gemcitabine+simvastatin	Gemcitabine and simvastatin
Gemcitabine+Placebo	Gemcitabine+Placebo	Gemcitabine plus Placebo

Primary Outcome Measures

Name	Time	Method
Time to progression	Every 2 cycles until progression

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of