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

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

Study Overview

• Status: Terminated
• Conditions: Cancer; Venous Thromboembolism
• Intervention / Treatment: Drug: Tinzaparin sodium

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: Interventional
• Enrollment (Actual): 131
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California
  • New York
    • New York, New York, United States, 10021
      • Cornell Weill Scholl of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: VTE Treatment Group	Drug: Tinzaparin sodium; Subcutaneous injection 175 U/Kg/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Development of recurrent venous thromboembolism and major hemorrhage.	up to 6 months on treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Secondary outcome measures will evaluate other thrombotic events, clinical cancer outcome, and plasma markers of hemostasis, fibrinolysis, and angiogenesis	6 months

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: Celgene Corporation

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (ACTUAL): October 1, 2012
• Study Completion (ACTUAL): October 1, 2015

Study Registration Dates

• First Submitted: September 18, 2009
• First Submitted That Met QC Criteria: September 21, 2009
• First Posted (ESTIMATE): September 22, 2009

Study Record Updates

• Last Update Posted (ACTUAL): July 6, 2017
• Last Update Submitted That Met QC Criteria: July 5, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: VTE in cancer patients
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
• Other Study ID Numbers: 0S-04-5