Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients

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

Sponsors

Lead Sponsor: Samsung Medical Center

Source 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.

Overall Status Completed
Start Date October 2008
Completion Date February 2014
Primary Completion Date September 2013
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Time to progression Every 2 cycles until progression
Secondary Outcome
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
Enrollment 106
Condition
Intervention

Intervention Type: Drug

Intervention Name: Gemcitabine+simvastatin

Description: Gemcitabine and simvastatin

Arm Group Label: Gemcitabine+simvastatin

Other Name: Gemcitabine and simvastatin

Intervention Type: Drug

Intervention Name: Gemcitabine+Placebo

Description: Gemcitabine plus Placebo

Arm Group Label: Gemcitabine+Placebo

Other Name: Gemcitabine plus Placebo

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Young Suk Park, M.D.,Ph.D. Principal Investigator Samsung Medical Center, Seoul, Korea
Location
Facility: Samsung Medical Center
Location Countries

Korea, Republic of

Verification Date

February 2017

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Samsung Medical Center

Investigator Full Name: Young Suk Park

Investigator Title: professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Gemcitabine+simvastatin

Type: Experimental

Description: Gemcitabine and simvastatin

Label: Gemcitabine+Placebo

Type: Placebo Comparator

Description: Gemcitabine plus Placebo

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov