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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

May 26, 2009
May 27, 2009
July 22, 2013
December 12, 2013
December 19, 2017
May 2009
April 2012   (Final data collection date for primary outcome measure)
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.
Assess the benefit of enoxaparin in preventing venous thromboembolic events in cancer patients with high levels of circulating tissue factor bearing microparticles (TFMP). [ Time Frame: 3 years ]
Complete list of historical versions of study NCT00908960 on ClinicalTrials.gov Archive Site
  • 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)
  • 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.
  • To Investigate the Safety of Prophylactic Enoxaparin in Cancer Patients (Major Bleeding Episodes). [ Time Frame: 3 years ]
  • To Assess the Impact of Enoxaparin on Overall Survival. [ Time Frame: 3 years ]
  • To investigate the cumulative incidence of symptomatic or proximal venous thromboembolic events (VTE) at 6 months. [ Time Frame: 3 years ]
  • To investigate the cumulative incidence of total VTE in cancer patients with low TFMP compared with those with high TFMP not treated with enoxaparin. [ Time Frame: 3 years ]
  • To assess the influence of chemotherapy or enoxaparin on TFMP levels [ Time Frame: 3 years ]
  • To assess the association between absolute TFMP levels and thrombotic risk [ Time Frame: 3 years ]
Not Provided
Not Provided
 
Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles
A Randomized Controlled Trial of Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Advanced Pancreatic, Colon, Lung, Gastric and Ovarian Cancer
Drug: Enoxaparin
Other Name: Lovenox
  • 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.
    Intervention: Drug: Enoxaparin
  • 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.
Zwicker JI, Liebman HA, Bauer KA, Caughey T, Campigotto F, Rosovsky R, Mantha S, Kessler CM, Eneman J, Raghavan V, Lenz HJ, Bullock A, Buchbinder E, Neuberg D, Furie B. Prediction and prevention of thromboembolic events with enoxaparin in cancer patients with elevated tissue factor-bearing microparticles: a randomized-controlled phase II trial (the Microtec study). Br J Haematol. 2013 Feb;160(4):530-7. doi: 10.1111/bjh.12163. Epub 2012 Dec 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
October 2012
April 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00908960
08-378
Yes
Not Provided
Not Provided
Jeffrey Zwicker, MD, Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
  • Massachusetts General Hospital
  • North Shore Medical Center
  • University of Southern California
  • VA Boston Healthcare System
  • Sanofi
Principal Investigator: Jeffrey Zwicker, MD Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP