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

Cancer Clinical Trial

Official title:

Anti-Platelet and Statin Therapy to Prevent Cancer-Associated Thrombosis: A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02285738
• Other study ID #: CASE8Y14
• Status: Completed
• Phase: Early Phase 1
• Start date: December 30, 2014
• Est. completion date: October 1, 2018

Study information

• Verified date: May 2019
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 1, 2018
• Est. primary completion date: July 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Solid Tumor
• Thrombosis

Intervention

Drug:
• Aspirin
81mg/day for 4 weeks
• Simvastatin
Daily dose of Simvastatin for 4 weeks

Other:
• Observation
participants will be observed for thrombotic evens for 4 weeks

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in average sP-selectin levels	Change in sP-selectin levels as indicator of measure efficacy	at 16 weeks of treatment
Secondary	Frequency of major bleeding complications or clinically significant non-bleeding complications per patient	The safety endpoint will be bleeding complications over 17 weeks (16 weeks of study plus an additional week of observation). This will include major bleeding events and clinically significant non-major bleeding events. A bleeding event will be defined as major if it satisfies one or more of the following: decrease in hemoglobin of 2 g/dL or more, leads to transfusion of two or more units of blood or packed cells, occurs in a critical site (intraocular, spinal/epidural, intracranial, retroperitoneal, or pericardial) or leads to death. Clinically significant, non-major bleeding will be defined as bleeding that does not meet the criteria for major bleeding, and has at least one of the following characteristics: multiple-source bleeding; spontaneous hematoma >25 cm2; epistaxis >5 min; macroscopic hematuria not related to instrumentation; spontaneous rectal bleeding; gingival bleeding > 5 min; hemoptysis; hematemesis; or prolonged bleeding (> 5 min) after venipuncture.	at 17 weeks after beginning treatment
Secondary	Change in average Platelet Factor 4	measure of efficacy using plasma level of platelet activation markers	at 16 weeks of treatment
Secondary	Change in average CD40 ligand	measure of efficacy using plasma level of platelet activation markers	at 16 weeks of treatment
Secondary	Change in average serum thromboxane B2	measure of efficacy using plasma level of platelet activation markers	at 16 weeks of treatment
Secondary	Change in average serum VEGF	measure of efficacy using plasma level of angiogenesis markers	at 16 weeks of treatment
Secondary	Change in average serum angiopoietin-2	measure of efficacy using plasma level of angiogenesis markers	at 16 weeks of treatment
Secondary	Change in average serum hepatocyte growth factor	measure of efficacy using plasma level of angiogenesis markers	at 16 weeks of treatment
Secondary	Change in average serum PECAM	measure of efficacy using plasma level of angiogenesis markers	at 16 weeks of treatment
Secondary	Change in average serum PDGF	measure of efficacy using plasma level of angiogenesis markers	at 16 weeks of treatment
Secondary	Change in average plasma F1.2	measure of efficacy using plasma level of hemostatic activation markers	at 16 weeks of treatment
Secondary	Change in average plasma TAT complexes	measure of efficacy using plasma level of hemostatic activation markers	at 16 weeks of treatment
Secondary	Change in average plasma D-dimer	measure of efficacy using plasma level of hemostatic activation markers	at 16 weeks of treatment
Secondary	Change in the number of thrombotic events	the number of thrombotic events measured by the number of events related to venus thrombosis, pulmonary embolism, visceral vein thrombosis as well as arterial thromboembolic events including stroke, myocardial infarction or arterial embolism	17 weeks after beginning treatment