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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
Results First Received: July 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Advanced Pancreatic, Colon, Lung, Gastric and Ovarian Cancer
Intervention: Drug: Enoxaparin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm A (High TFMP) Enoxaparin given subcutaneously daily for 2 months
Arm B (High TFMP) Observation
Arm C (Low TFMP) Observation

Participant Flow:   Overall Study
    Arm A (High TFMP)     Arm B (High TFMP)     Arm C (Low TFMP)  
STARTED     24     12     34  
COMPLETED     23     11     32  
NOT COMPLETED     1     1     2  
excluded from analysis                 1                 1                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm A (High TFMP) Enoxaparin given subcutaneously daily for 2 months
Arm B (High TFMP) Observation
Arm C (Low TFMP) Observation
Total Total of all reporting groups

Baseline Measures
    Arm A (High TFMP)     Arm B (High TFMP)     Arm C (Low TFMP)     Total  
Number of Participants  
[units: participants]
  23     11     32     66  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     10     4     19     33  
>=65 years     13     7     13     33  
Age  
[units: years]
Mean ± Standard Deviation
  65.3  ± 10.5     63.4  ± 15.0     63.3  ± 11.7     64.0  ± 11.8  
Gender  
[units: participants]
       
Female     9     6     13     28  
Male     14     5     19     38  
Region of Enrollment  
[units: participants]
       
United States     23     11     32     66  



  Outcome Measures

1.  Primary:   The Cumulative Incidence of VTE at 2 Months.   [ Time Frame: 2 months ]

2.  Secondary:   To Investigate the Safety of Prophylactic Enoxaparin in Cancer Patients (Major Bleeding Episodes).   [ Time Frame: 2 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   To Assess the Impact of Enoxaparin on Overall Survival.   [ Time Frame: years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jeffrey Zwicker, MD
Organization: Beth Israel Deaconess Medical Center
phone: 617-667-9299
e-mail: jzwicker@bidmc.harvard.edu


No publications provided


Responsible Party: Jeffrey Zwicker, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00908960     History of Changes
Other Study ID Numbers: 08-378
Study First Received: May 26, 2009
Results First Received: July 22, 2013
Last Updated: October 22, 2013
Health Authority: United States: Food and Drug Administration