Neoplasms Clinical Trial
Official title:
Impact of Rosuvastatin on Risk Markers of Venous Thromboembolism During Systemic Therapy for Advanced Cancer
Patients with cancer have a high risk of developing venous blood clots or thromboembolism
(VTE). In an effort to target patients at highest risk of VTE for thromboprophylaxis
(protective treatment for blood clots), numerous studies have identified serum biomarkers for
risk of future VTE. There is also increasing evidence pointing to a prophylactic effect of
statin therapy on the risk of developing VTE in high-risk populations including patients with
advanced cancer. The purpose of this research study is to find out whether treatment with
rosuvastatin (the study drug) reduces the risk of VTE in patients with cancer receiving
chemotherapy. This study is specifically investigating the impact of rosuvastatin therapy on
serum biomarkers (D-dimer and others) that indicate a risk for VTE, as well as safety and
tolerance of rosuvastatin therapy in this population.
This is a phase II randomized crossover study with two 3-4 week treatment periods during
which all enrolled patients will receive 20 mg of rosuvastatin once a day by mouth or a
matching placebo tablet. Approximately two tablespoons of blood will be collected for
biomarker analysis at the beginning and end of each treatment period. After the first
treatment period there will be a 3-5 week break where subjects will undergo a washout.
Following this washout period every subject will "crossover" or begin taking the alternative
therapy so everyone enrolled will receive the study drug either during the first or the
second treatment period. Biomarker levels will be analyzed in both treatment periods and
compared to baseline, with every patient acting as their own control.
n/a
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