Trial of Simvastatin and Gemcitabine in Pancreatic Cancer Patients

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944463
• Other study ID #: 2008-07-065
• Status: Completed
• Phase: Phase 2
• First received: July 21, 2009
• Last updated: February 15, 2017
• Start date: October 2008
• Est. completion date: February 2014

Study information

• Verified date: February 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: February 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Gemcitabine+simvastatin
Gemcitabine and simvastatin
• Gemcitabine+Placebo
Gemcitabine plus Placebo

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression		Every 2 cycles until progression
Secondary	Safety profiles of gemcitabine/simvastatin		Every cycle until progression
Secondary	Response rate		Every 2 cycles until progression
Secondary	Duration of response		Every 2 cycles until progression
Secondary	Overall survival		Every 3 months
Secondary	Correlative analyses		after completion of accrual