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Tinzaparin for Primary Treatment and Extended Secondary Prophylaxis of Venous Thromboembolism in Patients With Cancer

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ClinicalTrials.gov Identifier: NCT00981903
Recruitment Status : Terminated (Tinzaparin will no longer be available in the United States)
First Posted : September 22, 2009
Last Update Posted : July 6, 2017
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University of Southern California

Tracking Information
First Submitted Date  ICMJE September 18, 2009
First Posted Date  ICMJE September 22, 2009
Last Update Posted Date July 6, 2017
Study Start Date  ICMJE July 2005
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 21, 2009)
Development of recurrent venous thromboembolism and major hemorrhage. [ Time Frame: up to 6 months on treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00981903 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 21, 2009)
Secondary outcome measures will evaluate other thrombotic events, clinical cancer outcome, and plasma markers of hemostasis, fibrinolysis, and angiogenesis [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Tinzaparin for Primary Treatment and Extended Secondary Prophylaxis of Venous Thromboembolism in Patients With Cancer
Official Title  ICMJE Tinzaparin for Primary Treatment and Extended Secondary Prophylaxis of Venous Thromboembolism in Patients With Cancer
Brief Summary In this study the investigators will determine the safety and effectiveness of Tinzaparin in preventing blood clots for up to 12 months of treatment.
Detailed Description The purpose of this study is to use long-term administration of a low molecular weight heparin (tinzaparin) for primary treatment and secondary prophylaxis of venous thromboembolism in patients with cancer. We will determine the efficacy (recurrent VTE) and safety (major hemorrhage) of this approach. Secondarily, we will analyze the outcome of patients in terms of survival and response to therapy versus matched controls. We will also determine baseline levels of markers of hemostasis, fibrinolysis, and angiogenesis and will follow changes with treatment as well as correlate levels of these plasma markers with outcomes, including recurrent venous thromboembolism, major hemorrhage,and survival.
Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Venous Thromboembolism
  • Cancer
Intervention  ICMJE Drug: Tinzaparin sodium
Subcutaneous injection 175 U/Kg/day
Study Arms
  • Experimental: VTE Treatment Group
    Intervention: Drug: Tinzaparin sodium
  • No Intervention: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 23, 2013)
131
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date October 2015
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of active cancer
  • Patients have documented or recurrent malignancy and must meet at least one of the following criteria:

    • Diagnosis or documented presence of cancer within 6 months, excluding squamous cell or basal cell carcinoma of the skin OR
    • Receive any therapy for cancer within the previous 6 months OR
    • Currently receiving any treatment (surgery, radiation, chemotherapy, hormonal therapy, biotherapy, palliative therapy, and/or combined modality therapy) for cancer
  • Documented first venous thromboembolic event
  • Patients must meet at least one of the following criteria:

    • Deep vein thrombosis of the lower extremity confirmed with duplex ultrasonography, magnetic resonance imaging, or venogram OR
    • Pulmonary embolism confirmed with high probability V/Q scan, CT angiogram, or pulmonary angiogram
  • ECOG performance status of 0, 1, or 2
  • Signed written informed consent
  • Age 18 years or greater

Exclusion Criteria:

  • Body weight less than 40 kg
  • Recurrent spontaneous fractures unrelated to the underlying active malignancy
  • Administration of therapeutic doses of unfractionated or low molecular weight heparin for more than 48 hours prior to registration Amendment 3 (05/26/2009) 11
  • Need for long-term oral anticoagulant therapy (e.g., mechanical heart valves, atrial fibrillation)
  • Poor performance status with an ECOG score of 3 or 4
  • Serious hemorrhage requiring hospitalization, transfusion, or surgical intervention within 2 weeks of presentation
  • Known acute (symptomatic or active bleeding) gastroduodenal ulcer
  • Epidural/spinal puncture within the last 24 hours
  • Neurosurgery within 1 week of registration or any previous history of intracranial hemorrhage
  • Septic endocarditis
  • Overt pericardial effusion
  • Current platelet count of less than 50 x 109/L
  • Undergoing high dose chemotherapy for peripheral blood stem cell or bone marrow transplantation, induction chemotherapy for acute leukemia, or has other conditions associated with persistent thrombocytopenia of less than 100 109/L for a duration of at least four consecutive weeks
  • Familial bleeding diathesis
  • Uncontrolled hypertension despite antihypertensive therapy
  • Dependent upon renal dialysis or significant renal failure with a serum creatinine of greater than three times the upper limit of normal
  • Allergy to heparin (unfractionated or low molecular weight)
  • Allergy to contrast medium
  • Pregnant or of childbearing potential and not using adequate contraception
  • Geographically inaccessible for follow-up
  • Failure or inability to give informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00981903
Other Study ID Numbers  ICMJE 0S-04-5
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE Celgene Corporation
Investigators  ICMJE Not Provided
PRS Account University of Southern California
Verification Date July 2017

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