Detecting the Impact of Statin Therapy On Lowering Risk of Venous Thrombo-Embolic Events (DISOLVE)
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/12/2018 |
| Start Date: | March 2012 |
| End Date: | September 1, 2016 |
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.
(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.
Inclusion Criteria:
- Adult patients > 18 years old with locally-advanced or metastatic cancers who are
about to start or are already receiving any systemic chemotherapy or targeted therapy.
- Estimated overall survival of ≥ 6 months
- Anticipated duration of therapy ≥ 9 weeks (if 3-week cycle) or ≥ 12 weeks (if 2 or
4-week cycle). Systemic therapy is allowed to change if necessary, or to terminate,
during this period
Exclusion Criteria:
- Antithrombotic therapy including warfarin, dabigatran, low molecular weight heparin or
unfractionated heparin. Patients taking aspirin may participate in this study.
- Anti-angiogenic therapy with thalidomide or lenalidomide. Patients receiving
bevacizumab may participate in this study.
- Patients starting hormonal therapy exclusively, such as SERM or aromatase inhibitor
therapy for breast cancer, or androgen-ablative therapy for prostate cancer.
- Statin use within 3 months prior to enrolment
- Adjuvant therapy in patients who have already received curative-intent local therapy
(surgery or radiotherapy). Patients with glioblastoma starting adjuvant chemotherapy
are an exception given the high likelihood of residual disease and risk of VTE in this
population.
- Asian descent as assessed by history. If either of the participant's parents is Asian
(peoples of East, Southeast, and South Asia), a patient will be excluded due to slower
metabolism of the drug and concerns regarding toxicity at the 20 mg dose level.
- Urinary creatinine clearance of less than 40 ml/min based on reported MDRD GFR,
present in FAHC metabolic profile reports, during the 14 day screening period.
- AST or ALT elevation of greater than 3X upper limit of normal, during the 14 day
screening period.
- Patients with a known history of statin intolerance that was accompanied by severe
adverse reaction.
- Patients who are currently participating in another clinical trial involving an
investigational medication if there is a known or suspected drug interaction with
rosuvastatin or the statin class, or if the investigational agent is known or
suspected to be associated with a significantly increased risk of thrombosis.
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