Rosuvastatin to Lower Circulating Tissue Factor Bearing Microparticles in Metastatic Breast Cancer
This study is currently recruiting participants.
Verified November 2012 by Dana-Farber Cancer Institute
Sponsor:
Beth Israel Deaconess Medical Center
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: November 1, 2012
Last verified: November 2012
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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 lovers 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 by Wilcoxon signed-rank test for each arm.
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 will be performed by Mann-Whitney U test.
- 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 by assessing the Spearman's rand correlation coefficient.
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2010 |
| Estimated Primary Completion Date: | December 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01299038
Contacts
| Contact: Jeffrey B. Zwicker, MD | 617-667-9299 |
Locations
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: Jeffrey B. Zwicker, MD | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Principal Investigator: Erica Mayer, MD | |
| Massachusetts General Hospital | Not yet recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: Steven Isakoff, MD | |
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: | November 1, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Dana-Farber Cancer Institute:
|
Crestor TFBP rosuvastatin |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Thromboplastin Rosuvastatin Hemostatics Coagulants Hematologic Agents |
Therapeutic Uses Pharmacologic Actions Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Lipid Regulating Agents |
ClinicalTrials.gov processed this record on May 19, 2013