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

Case Comprehensive Cancer Center (Case CCC)

Status and phase: Completed; Early Phase 1

Conditions: Solid Tumor; Cancer

Treatments: Drug: Aspirin; Drug: Simvastatin; Other: Observation

Study type: Interventional

Funder types: Other

Identifiers

NCT02285738

CASE8Y14

Details and patient eligibility

About

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.

Full description

Objectives

Primary: To determine efficacy of aspirin with and without simvastatin in solid tumor patients at high- or intermediate-risk for VTE, in reducing markers of platelet activation, levels of inflammatory and angiogenic cytokines measured using high-throughput approaches, and clinical and investigational measures of hemostatic activation.

Secondary: To determine safety and feasibility of aspirin with or without simvastatin in solid tumor patients at high- or intermediate-risk for VTE

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 6 patient groups

Aspirin+Asprin/Simvastatin+Observation (ASO)

Active Comparator group

Description:

Aspirin 81mg/day for 4 weeks followed by 2-week washout, followed by 4 weeks of Aspirin 81mg/day with daily dose of Simvastatin with a 2-week washout period, ending with 4 weeks of observation

Treatment:

Other: Observation

Drug: Aspirin

Drug: Simvastatin

Aspirin+Observation+Asprin/Simvastatin (AOS)

Experimental group

Description:

Aspirin 81mg/day for 4 weeks followed by 2-week washout, followed by 4 weeks of observation with 2-week washout, ending with Aspirin 81mg/day with daily dose of Simvastatin

Treatment:

Other: Observation

Drug: Aspirin

Drug: Simvastatin

Aspirin/Simvastatin+Observation+Asprin (SOA)

Experimental group

Description:

Aspirin 81mg/day for 4 weeks with daily dose of Simvastatin followed by 2-week washout, followed by 4 weeks of observation with 2-week washout, ending with Aspirin 81mg/day

Treatment:

Other: Observation

Drug: Aspirin

Drug: Simvastatin

Aspirin/Simvastatin+Asprin+Observation (SAO)

Experimental group

Description:

Aspirin 81mg/day for 4 weeks with daily dose of Simvastatin followed by 2-week washout, followed by 4 weeks of Aspirin 81mg/day and a 2-week washout, ending with observation for 4 weeks.

Treatment:

Other: Observation

Drug: Aspirin

Drug: Simvastatin

Observation+Aspirin/Simvastatin+Asprin (OSA)

Experimental group

Description:

Observation for 4 weeks with 2-week washout, followed by Aspirin 81mg/day for 4 weeks with daily dose of Simvastatin followed by 2-week washout, ending with Aspirin 81mg/day for 4 weeks.

Treatment:

Other: Observation

Drug: Aspirin

Drug: Simvastatin

Observation+Aspirin+Asprin/Simvastatin (OAS)

Experimental group

Description:

Observation for 4 weeks with 2-week washout, followed by Aspirin 81mg/day for 4 weeks followed by 2-week washout, ending with Aspirin 81mg/day for 4 weeks with daily dose of Simvastatin.

Treatment:

Other: Observation

Drug: Aspirin

Drug: Simvastatin