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

NCT ID: NCT00981903

Last Updated: 2017-07-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2015-10-31

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.

Conditions

Venous Thromboembolism; Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

VTE Treatment Group

Group Type: EXPERIMENTAL

Tinzaparin sodium

Intervention Type: DRUG

Subcutaneous injection 175 U/Kg/day

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tinzaparin sodium

Subcutaneous injection 175 U/Kg/day

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Southern California

Los Angeles, California, United States

Cornell Weill Scholl of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

0S-04-5

Identifier Type: -

Identifier Source: org_study_id