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Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles (MicroTEC)

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ClinicalTrials.gov Identifier: NCT00908960
Recruitment Status : Completed
First Posted : May 27, 2009
Results First Posted : December 12, 2013
Last Update Posted : December 19, 2017
Sponsor:
Collaborators:
Massachusetts General Hospital
North Shore Medical Center
University of Southern California
VA Boston Healthcare System
Sanofi
Information provided by (Responsible Party):
Jeffrey Zwicker, MD, Dana-Farber Cancer Institute

Brief Summary:
Research studies have shown a strong association between cancer and blood clots in the veins (also known as deep vein thrombosis). These blood clots can flow to the lungs (pulmonary embolism) which in severe cases may be life threatening. The purpose of this research study is to see if enoxaparin is effective in preventing blood clots in the veins in participants who have cancer of the pancreas, colorectal, non-small cell lung, ovary, or gastric and also have high levels of tissue factor bearing microparticles in their blood (TFMP). TFMP are small particles that are generated from different types of blood cells in the body. In people who have cancer, TFMP are thought to be generated from cancer cells and may represent a risk factor for deep vein thrombosis. Enoxaparin has been used to prevent formation of blood clots in patients after abdominal or orthopedic surgery and in patients who suffer from a severe medical illness. Based on these studies, we are investigating to see if it prevents thrombosis in people with certain types of cancer.

Condition or disease Intervention/treatment Phase
Advanced Pancreatic, Colon, Lung, Gastric and Ovarian Cancer Drug: Enoxaparin Phase 2

Detailed Description:
The study was a randomized phase II trial to evaluate the cumulative incidence of VTE in cancer outpatients. At baseline, measurement of tissue factor-bearing microparticles (TFMP) was performed by impedance-based flow cytometry based on established methods. (Zwicker et al, 2009) Patients were classified as having high or low TFMP levels based on a reference repository of plasmas from sixty cancer patients. The top tercile of tissue factor-bearing microparticle concentrations from the reference specimens (3.5 x 104 microparticles/µl) was considered a cutoff for "high" and corresponds with previously described "detectable" levels. Patients with high levels were randomized (2:1) to enoxaparin 40 mg subcutaneously once daily or observation. Randomization was stratified based on cancer diagnosis. Low TFMP patients were observed without anticoagulation. Both the treating physicians and patients were blinded to microparticle status in the observation arms.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles
Study Start Date : May 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: High TFMP: Enoxaparin
Patients received enoxaparin 40 mg subcutaneously once daily for 2 months (60 days).Only patients with high TFMP status at baseline were randomized to treatment or observation.
Drug: Enoxaparin
Other Name: Lovenox
No Intervention: High TFMP: Observation
Patients undergo observation until evaluation with a lower extremity ultrasound at 2 months (day 60). Only patients with high TFMP status at baseline were randomized to treatment or observation.
No Intervention: Low TFMP: Observation
Patients undergo observation until evaluation with a lower extremity ultrasound at 2 months (day 60). Patients with low TFMP status at baseline were directly assigned to observation.



Primary Outcome Measures :
  1. 2-Month Cumulative Incidence of VTE [ Time Frame: Assessment with lower extremity ultrasound occured at day 60/ month 2 ]
    2-month cumulative incidence of venous thromboembolism (VTE) is the probability of experiencing within 2 months of study entry the following events: any symptomatic proximal or distal lower extremity deep vein thrombosis, symptomatic pulmonary embolism or fatal pulmonary embolism diagnosed by autopsy, or asymptomatic proximal deep vein thrombosis diagnosed by screening compression ultrasound.


Secondary Outcome Measures :
  1. Incidence of Major Hemorrhage Events [ Time Frame: Assessed during the 60 day therapy ]
    Incidence is the number of patients experiencing at least one major hemorrhage events as defined according to International Society on Thrombosis and Haemostasis (ISTH) guidelines. (Schulman and Kearon 2005)

  2. Overall Survival [ Time Frame: Assessed up to approximately 30 months ]
    Overall survival is defined as the time from study entry to death or date last known alive and estimated using Kaplan-Meier (KM) methods.



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

Inclusion Criteria:

  • Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative therapies do not exist. Eligible malignancies include:

    • Adenocarcinoma of the pancreas (locally advanced or metastatic)
    • Colorectal (stage IV)
    • Non-small cell lung (unresectable stage III or IV)
    • Relapsed ovarian or stage IV
    • Surgically unresectable or metastatic gastric adenocarcinoma
  • First or second line therapy (within 4 weeks of initiating therapy).
  • Minimum age 18 years
  • Life expectancy of greater than 6 months
  • ECOG Performance Status 0, 1, or 2 (Karnofsky 60% or greater).
  • Participants must have normal organ and marrow function as outlined in the protocol.

Exclusion Criteria:

  • Participants may not be receiving any other study agents.
  • Known brain metastases should be excluded from this clinical trial because of their poor prognosis and higher potential for intracranial hemorrhage.
  • Prior history of documented venous thromboembolic event or pulmonary embolism within the last 5 years years (excluding central line associated events whereby patients completed anticoagulation > 3 months previously)
  • Active bleeding or high risk for bleeding (e.g. known acute gastrointestinal ulcer)
  • Any history of significant hemorrhage (requiring hospitalization or transfusion) outside of a surgical setting within the last 5 years
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to enoxaparin or heparin.
  • History of heparin-induced thrombocytopenia
  • Presence of coagulopathy (PT or PTT> 1.5 x upper limit of normal)
  • Familial bleeding diathesis
  • Known diagnosis of disseminated intravascular coagulation
  • Currently receiving anticoagulant therapy
  • Current use of aspirin (>81mg daily), Clopidogrel (Plavix), cilostazol (Pletal), aspirin-dipyridamole (Aggrenox), or regular use of non-steroidal anti-inflammatory agents more than twice weekly. Maximum dose of ibuprofen is 400mg no more than twice per week.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

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): NCT00908960


Locations
United States, California
University of Southern California-Keck School of Medicine
Los Angeles, California, United States, 90033
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
VA Boston Healthcare System
Boston, Massachusetts, United States, 02130
Mass General/North Shore Cancer Center
Danvers, Massachusetts, United States, 01923
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Massachusetts General Hospital
North Shore Medical Center
University of Southern California
VA Boston Healthcare System
Sanofi
Investigators
Principal Investigator: Jeffrey Zwicker, MD Beth Israel Deaconess Medical Center

Publications of Results:
Responsible Party: Jeffrey Zwicker, MD, Attending Physician, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00908960     History of Changes
Other Study ID Numbers: 08-378
First Posted: May 27, 2009    Key Record Dates
Results First Posted: December 12, 2013
Last Update Posted: December 19, 2017
Last Verified: November 2017

Keywords provided by Jeffrey Zwicker, MD, Dana-Farber Cancer Institute:
enoxaparin

Additional relevant MeSH terms:
Thromboplastin
Hemostatics
Coagulants