Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment rosuvastatin
Phase phase 2
Sponsor Beth Israel Deaconess Medical Center
Collaborator Dana-Farber Cancer Institute
Start date October 2010
End date December 2016
Trial size 20 participants
Trial identifier NCT01299038, 10-287

Summary

Research studies have shown a strong association between cancer and blood clots in the veins (also known as deep vein thrombosis). These blood clots can flow to the lungs (pulmonary embolism) which in severe cases may be life threatening. Studies have demonstrated that increases in microparticles may contribute to the development of deep vein thrombosis in cancer patients. The purpose of this research study is to see if rosuvastatin lowers the number of tissue factor bearing microparticles in the blood (TFMP). TFMP are small particles that are generated from different types of blood cells in the body. In people who have cancer, TFMP are thought to be generated from cancer cells and may represent a risk factor for deep vein thrombosis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
Rosuvastatin 20mg taken orally once a day for 4 weeks
rosuvastatin Crestor
Taken orally once a day for 4 weeks
(Active Comparator)
Rosuvastatin 40mg taken orally once a day for 4 weeks
rosuvastatin Crestor
Taken orally once a day for 4 weeks

Primary Outcomes

Measure
Reduction of tissue factor bearing microparticles
time frame: 4 weeks

Secondary Outcomes

Measure
Safety
time frame: 4 weeks
Reduction of rho kinase activity and RHO-A membrane localization
time frame: 4 weeks
Correlation between tissue factor bearing microparticle levels and hemostatic parameters
time frame: 4 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Metastatic adenocarcinoma of the breast (Stage IV) - Actively receiving endocrine therapy for at least 6 weeks (with or without HER2 therapy) - Minimum age 18 years - ECOG Performance status of 0, 1 or 2 - Normal organ and marrow function as defined in the protocol Exclusion Criteria: - Participants may not be receiving any other study agents - Actively receiving chemotherapy (exclusive of hormonal or HER2 therapy ) within last 5 weeks - Any statin therapy within the last 3 weeks - Asian decent (including Filipino, Chinese, Japanese, Korean, Vietnamese or Asian-Indian origin) - Concomitant use of the following drugs: cyclosporine, fibrates, niacin, gemfibrozil, ketaconazole, spironolactone, cimetidine, warfarin, erythromycin, or protease inhibitors - Conditions predisposing to renal failure secondary to rhabdomyolysis - Recent history of heavy alcohol use as judged by the treating physician - Known to be pregnant (testing not required) or nursing - History of rhabdomyolysis on statin therapy - Known history of Hepatitis C or active hepatitis B infection (baseline testing not required) - Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, hepatitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Additional Information

Official title A Multi-dose Phase II Trial of Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer
Principal investigator Jeffrey B. Zwicker, MD
Description - Since no one knows which of the study options are best, participants will be "randomized" into the following study groups: Group 1 (regular dose of rosuvastatin) or Group 2 (higher dose of rosuvastatin). - Participants will take 1 pill of rosuvastatin every day for 4 weeks. Each 4 week period is called a cycle. - Participants will have a physical exam at baseline, on day 1 of starting rosuvastatin, and 2 month visits. Laboratory tests will be taken at baseline, on day 1 of starting rosuvastatin, 6 weeks and 2 months.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Dana-Farber Cancer Institute.