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Anti-Platelet and Statin Therapy to Prevent Cancer-Associated Thrombosis

Sponsored by Case Comprehensive Cancer Center

Phase Quota
Phase 0

This research study examines the safety and feasibility of aspirin with or without Simvastatin in solid tumor patients at risk for VTE (Venous Thromboembolism - or blood clots - in the arms, lets, lungs, or other part of the body). One-fifth of all thrombotic (clotting) events occur in patients that have cancer. Changes in sP-selectin will be used as a measure of efficacy. We have chosen sP-selectin as the primary marker because of its role in hemostasis, because it is predictive of thrombosis in cancer patients and because of promising preliminary data. We expect that sP-selectin levels will be elevated in patients before therapy with aspirin and/or statin, but that these levels will fall significantly during treatment, rise during the observation phase, and fall during the second study period. Patients who take part in the study have been diagnosed with a solid tumor cancer and are considered to be intermediate to high risk for VTE. The standard of care is to give chemotherapy for solid tumors and treat clots which develop using blood thinners.

Study Start Date: December 2014

Estimated Completion Date: August 2016

Specialties: Cardiology: Clinical Pharmacology Pharmacy: Cardiac/Hypertension Physician Assistant: Cardiology,Clinical Pharmacology

Interventions

  • Other: Observation
  • Drug: Simvastatin
  • Drug: Aspirin

Inclusion criteria

  • Histologic diagnosis of malignancy of a solid organ
  • Planned to initiate a new systemic chemotherapy regimen (including patients starting on first chemotherapy or patients previously treated but starting on a new regimen)
  • VTE Risk Score ?1
  • Written, informed consent

Exclusion criteria

  • Hematologic malignancies including acute and chronic leukemias, myelodysplastic syndromes, lymphoma and myeloma
  • Active bleeding or high risk of bleeding in the opinion of the investigator
  • Hepatic dysfunction (elevated transaminases or bilirubin > 3 times normal)
  • Planned stem cell transplant
  • Life expectancy < 6 months
  • Acute or chronic renal insufficiency with creatinine clearance < 30 mL/min
  • Pregnancy
  • Known allergy to or prior intolerance of aspirin and/or simvastatin
  • Ongoing anticoagulant, statin and/or anti-platelet therapy

Study Locations And Contact Information

  • Cleveland Clinic Taussig Cancer institute Case Comprehensive Cancer Center, Cleveland Ohio
    Contact: Alok A Khorana MD 216-636-2690 khorana@ccf.org

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