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

Primary Purpose

Venous Thromboembolism, Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tinzaparin sodium
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Venous Thromboembolism focused on measuring VTE in cancer patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Southern California
  • Cornell Weill Scholl of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

VTE Treatment Group

Control

Arm Description

Outcomes

Primary Outcome Measures

Development of recurrent venous thromboembolism and major hemorrhage.

Secondary Outcome Measures

Secondary outcome measures will evaluate other thrombotic events, clinical cancer outcome, and plasma markers of hemostasis, fibrinolysis, and angiogenesis

Full Information

First Posted
September 18, 2009
Last Updated
July 5, 2017
Sponsor
University of Southern California
Collaborators
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00981903
Brief Title
Tinzaparin for Primary Treatment and Extended Secondary Prophylaxis of Venous Thromboembolism in Patients With Cancer
Official Title
Tinzaparin for Primary Treatment and Extended Secondary Prophylaxis of Venous Thromboembolism in Patients With Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Tinzaparin will no longer be available in the United States
Study Start Date
July 2005 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
Celgene Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism, Cancer
Keywords
VTE in cancer patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VTE Treatment Group
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Tinzaparin sodium
Intervention Description
Subcutaneous injection 175 U/Kg/day
Primary Outcome Measure Information:
Title
Development of recurrent venous thromboembolism and major hemorrhage.
Time Frame
up to 6 months on treatment
Secondary Outcome Measure Information:
Title
Secondary outcome measures will evaluate other thrombotic events, clinical cancer outcome, and plasma markers of hemostasis, fibrinolysis, and angiogenesis
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cornell Weill Scholl of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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