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

This study is currently recruiting participants.
Verified March 2017 by Case Comprehensive Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02285738
First Posted: November 7, 2014
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
  Purpose
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.

Condition Intervention Phase
Solid Tumor Cancer Drug: Aspirin Drug: Simvastatin Other: Observation Early Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Anti-Platelet and Statin Therapy to Prevent Cancer-Associated Thrombosis: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Change in average sP-selectin levels [ Time Frame: at 16 weeks of treatment ]
    Change in sP-selectin levels as indicator of measure efficacy


Secondary Outcome Measures:
  • Frequency of major bleeding complications or clinically significant non-bleeding complications per patient [ Time Frame: at 17 weeks after beginning treatment ]
    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.

  • Change in average Platelet Factor 4 [ Time Frame: at 16 weeks of treatment ]
    measure of efficacy using plasma level of platelet activation markers

  • Change in average CD40 ligand [ Time Frame: at 16 weeks of treatment ]
    measure of efficacy using plasma level of platelet activation markers

  • Change in average serum thromboxane B2 [ Time Frame: at 16 weeks of treatment ]
    measure of efficacy using plasma level of platelet activation markers

  • Change in average serum VEGF [ Time Frame: at 16 weeks of treatment ]
    measure of efficacy using plasma level of angiogenesis markers

  • Change in average serum angiopoietin-2 [ Time Frame: at 16 weeks of treatment ]
    measure of efficacy using plasma level of angiogenesis markers

  • Change in average serum hepatocyte growth factor [ Time Frame: at 16 weeks of treatment ]
    measure of efficacy using plasma level of angiogenesis markers

  • Change in average serum PECAM [ Time Frame: at 16 weeks of treatment ]
    measure of efficacy using plasma level of angiogenesis markers

  • Change in average serum PDGF [ Time Frame: at 16 weeks of treatment ]
    measure of efficacy using plasma level of angiogenesis markers

  • Change in average plasma F1.2 [ Time Frame: at 16 weeks of treatment ]
    measure of efficacy using plasma level of hemostatic activation markers

  • Change in average plasma TAT complexes [ Time Frame: at 16 weeks of treatment ]
    measure of efficacy using plasma level of hemostatic activation markers

  • Change in average plasma D-dimer [ Time Frame: at 16 weeks of treatment ]
    measure of efficacy using plasma level of hemostatic activation markers

  • Change in the number of thrombotic events [ Time Frame: 17 weeks after beginning treatment ]
    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


Estimated Enrollment: 42
Actual Study Start Date: December 30, 2014
Estimated Study Completion Date: October 1, 2017
Estimated Primary Completion Date: October 1, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aspirin+Asprin/Simvastatin+Observation
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
Drug: Aspirin
81mg/day for 4 weeks
Drug: Simvastatin
Daily dose of Simvastatin for 4 weeks
Other: Observation
participants will be observed for thrombotic evens for 4 weeks
Experimental: Aspirin+Observation+Asprin/Simvastatin
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
Drug: Aspirin
81mg/day for 4 weeks
Drug: Simvastatin
Daily dose of Simvastatin for 4 weeks
Other: Observation
participants will be observed for thrombotic evens for 4 weeks
Experimental: Aspirin/Simvastatin+Observation+Asprin
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
Drug: Aspirin
81mg/day for 4 weeks
Drug: Simvastatin
Daily dose of Simvastatin for 4 weeks
Other: Observation
participants will be observed for thrombotic evens for 4 weeks
Experimental: Aspirin/Simvastatin+Asprin+Observation
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.
Drug: Aspirin
81mg/day for 4 weeks
Drug: Simvastatin
Daily dose of Simvastatin for 4 weeks
Other: Observation
participants will be observed for thrombotic evens for 4 weeks
Experimental: Observation+Aspirin/Simvastatin+Asprin
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.
Drug: Aspirin
81mg/day for 4 weeks
Drug: Simvastatin
Daily dose of Simvastatin for 4 weeks
Other: Observation
participants will be observed for thrombotic evens for 4 weeks
Experimental: Observation+Aspirin+Asprin/Simvastatin
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.
Drug: Aspirin
81mg/day for 4 weeks
Drug: Simvastatin
Daily dose of Simvastatin for 4 weeks
Other: Observation
participants will be observed for thrombotic evens for 4 weeks

Detailed 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285738


Contacts
Contact: Alok A Khorana, MD 216-636-2690 khorana@ccf.org

Locations
United States, Ohio
Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Alok A Khorana, MD    216-636-2690    khorana@ccf.org   
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Alok A Khorana, MD Case Comprehensive Cancer Center
  More Information

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02285738     History of Changes
Other Study ID Numbers: CASE8Y14
First Submitted: November 5, 2014
First Posted: November 7, 2014
Last Update Posted: March 29, 2017
Last Verified: March 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Case Comprehensive Cancer Center:
solid tumor, cancer, simvastatin, aspirin, blood clot, VTE, venous thromboembolism

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Aspirin
Simvastatin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors