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

Sponsor

University of Southern California (Other)

Overall Status

Terminated

CT.gov ID

NCT00981903

Collaborator

Celgene Corporation (Industry)

131

Enrollment

Locations

Arms

123

Duration (Months)

65.5

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Thromboembolism Cancer	Drug: Tinzaparin sodium	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

131 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jul 1, 2005

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VTE Treatment Group	Drug: Tinzaparin sodium Subcutaneous injection 175 U/Kg/day
No Intervention: Control

Arm

Intervention/Treatment

Experimental: VTE Treatment Group

Drug: Tinzaparin sodium

Subcutaneous injection 175 U/Kg/day

No Intervention: Control

Outcome Measures

Primary Outcome Measures

Development of recurrent venous thromboembolism and major hemorrhage. [up to 6 months on treatment]

Secondary Outcome Measures

Secondary outcome measures will evaluate other thrombotic events, clinical cancer outcome, and plasma markers of hemostasis, fibrinolysis, and angiogenesis [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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