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:
USC/Norris Comprehensive Cancer Center
Information provided by (Responsible Party):
USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00981903
First received: September 18, 2009
Last updated: May 23, 2013
Last verified: May 2013
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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 USC/Norris Comprehensive Cancer Center:
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
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
USC/Norris Comprehensive Cancer Center
More Information
No publications provided
| Responsible Party: | USC/Norris Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00981903 History of Changes |
| Other Study ID Numbers: | 0S-04-5 |
| Study First Received: | September 18, 2009 |
| Last Updated: | May 23, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by USC/Norris Comprehensive Cancer Center:
|
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 June 18, 2013