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Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Massachusetts General Hospital
Information provided by (Responsible Party):
Jeffrey Zwicker, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01299038
First received: February 16, 2011
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: rosuvastatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Multi-dose Phase II Trial of Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • Reduction of tissue factor bearing microparticles [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Assess the reduction of tissue factor bearing microparticles in metastatic breast cancer treated with 4 weeks of rosuvastatin


Secondary Outcome Measures:
  • Safety [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Investigate the safety of rosuvastatin in breast cancer patients. All participants will be evaluated for toxicity from the time of their first dose of rosuvastatin.

  • Reduction of rho kinase activity and RHO-A membrane localization [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Comparison of rho kinase activity and RHO-A translocation

  • Correlation between tissue factor bearing microparticle levels and hemostatic parameters [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Correlation between complete blood count, d-dimer, C-reactive protein, ROCK activity and TFMP will be determined


Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group 1
Rosuvastatin 20mg taken orally once a day for 4 weeks
Drug: rosuvastatin
Taken orally once a day for 4 weeks
Other Name: Crestor
Active Comparator: Group 2
Rosuvastatin 40mg taken orally once a day for 4 weeks
Drug: rosuvastatin
Taken orally once a day for 4 weeks
Other Name: Crestor

Detailed 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01299038

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Massachusetts General Hospital
Investigators
Principal Investigator: Jeffrey B. Zwicker, MD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: Jeffrey Zwicker, MD, Assistant Professor, Harvard Medical School, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01299038     History of Changes
Other Study ID Numbers: 10-287
Study First Received: February 16, 2011
Last Updated: March 17, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
Crestor
TFBP
rosuvastatin

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Rosuvastatin
Thromboplastin
Anticholesteremic Agents
Antimetabolites
Coagulants
Enzyme Inhibitors
Hematologic Agents
Hemostatics
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014