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

This study has been terminated.
(Tinzaparin will no longer be available in the United States)
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT00981903
First received: September 18, 2009
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

In this study the investigators will determine the safety and effectiveness of Tinzaparin in preventing blood clots for up to 12 months of treatment.


Condition Intervention Phase
Venous Thromboembolism
Cancer
Drug: Tinzaparin sodium
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Tinzaparin for Primary Treatment and Extended Secondary Prophylaxis of Venous Thromboembolism in Patients With Cancer

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Development of recurrent venous thromboembolism and major hemorrhage. [ Time Frame: up to 6 months on treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Secondary outcome measures will evaluate other thrombotic events, clinical cancer outcome, and plasma markers of hemostasis, fibrinolysis, and angiogenesis [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 131
Study Start Date: July 2005
Estimated Study Completion Date: October 2014
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VTE Treatment Group Drug: Tinzaparin sodium
Subcutaneous injection 175 U/Kg/day
No Intervention: Control

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00981903

Locations
United States, California
University of Southern California
Los Angeles, California, United States, 90033
United States, New York
Cornell Weill Scholl of Medicine
New York, New York, United States, 10021
Sponsors and Collaborators
University of Southern California
Celgene Corporation
  More Information

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT00981903     History of Changes
Other Study ID Numbers: 0S-04-5
Study First Received: September 18, 2009
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
VTE in cancer patients

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Tinzaparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on August 21, 2014