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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00908960
First received: May 26, 2009
Last updated: October 22, 2013
Last verified: October 2013

May 26, 2009
October 22, 2013
May 2009
April 2012   (final data collection date for primary outcome measure)
The Cumulative Incidence of VTE at 2 Months. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
The cumulative incidence of VTE at 2 months in the higher Venous thromboembolic events in cancer patients with high levels of circulating tissue factor bearing microparticles (TFMP).
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00908960 on ClinicalTrials.gov Archive Site
  • To Investigate the Safety of Prophylactic Enoxaparin in Cancer Patients (Major Bleeding Episodes). [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
  • To Assess the Impact of Enoxaparin on Overall Survival. [ Time Frame: years ] [ Designated as safety issue: No ]
  • To investigate the safety of prophylactic enoxaparin in cancer patients (major bleeding episodes). [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • To assess the impact of enoxaparin on overall survival. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To investigate the cumulative incidence of symptomatic or proximal venous thromboembolic events (VTE) at 6 months. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To assess the influence of chemotherapy or enoxaparin on TFMP levels [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To assess the association between absolute TFMP levels and thrombotic risk [ Time Frame: 3 years ] [ Designated as safety issue: No ]
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.

  • Because no one knows which of the study options is best, participants will be randomized into one of the following study groups. Participants who have high levels of TFMP in their blood will be in one of the two arms indicated.
  • Arm A (High TFMP): Enoxaparin given subcutaneously (into the skin) daily for 2 months, and lower extremity ultrasound performed at 2 months.
  • Arm B (High TFMP): Observation, lower extremity ultrasound performed at 2 months.
  • Arm C (Low TFMP): Observation, lower extremity ultrasound performed at 2 months.
  • At 2 months, participants will have a physical examination and will be asked questions about their general health and specific questions about any problems they might be having. They will also have a lower extremity ultrasound and blood tests performed at 2 months.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Advanced Pancreatic, Colon, Lung, Gastric and Ovarian Cancer
Drug: Enoxaparin
Given subcutaneously daily for 2 months
  • Experimental: Arm A (high TFMP)
    Enoxaparin given subcutaneously daily for 2 months
    Intervention: Drug: Enoxaparin
  • No Intervention: Arm B (high TFMP)
    Observation
  • No Intervention: Arm C (low TFMP)
    Observation
Not Provided

*   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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00908960
08-378
Yes
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
October 2013

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