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

Completed · Early Phase 1

Conditions studied: Solid Tumor, Cancer

In brief

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.

Key facts

Study ID

NCT02285738

Run by

Case Comprehensive Cancer Center

People needed

17

Starts

2014-12-30

Expected to finish

2018-10-01

Last updated by the study team

2019-05-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologic diagnosis of malignancy of a solid organ or lymphoma
• 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.

You may not qualify if…

• Hematologic malignancies including acute and chronic leukemias, myelodysplastic syndromes, lymphoma and myeloma
• Primary brain tumors
• 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.

Where it is running

• Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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