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Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With a Venous Thromboembolism

This study has been terminated.
(Study accrual stopped due to poor accrual.)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Daniel Budman, Northwell Health
ClinicalTrials.gov Identifier:
NCT00423683
First received: January 17, 2007
Last updated: May 6, 2016
Last verified: May 2016
  Purpose
The development of clots is a potentially deadly complication in many cancer patients. The current optimal treatment is unknown. Evidence supporting the effectiveness of the use of Inferior Vena Caval Filters is lacking. This study will compare the two standard of care treatment options: anticoagulation with or without a inferior vena cava filter. The anticoagulation medication chosen will be Arixtra and it will be given once a day as an injection. Patients will be called at various intervals to monitor their signs and symptoms of new thromboembolisms.

Condition Intervention Phase
Cancer
Thromboembolism
Drug: Arixtra alone
Device: Arixtra + filter
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Control Trial of Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With A Venous Thromboembolism

Resource links provided by NLM:


Further study details as provided by Northwell Health:

Primary Outcome Measures:
  • Adverse Outcomes [ Time Frame: 3 years or until death ] [ Designated as safety issue: Yes ]
    Rates of VCF complications, bleeding, and recurrent or residual DVTs or PEs


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 3 years or until death ] [ Designated as safety issue: Yes ]
  • Resolution of DVT [ Time Frame: 3 years or until death ] [ Designated as safety issue: Yes ]
  • Resolution of PE [ Time Frame: 3 years or until death ] [ Designated as safety issue: Yes ]

Enrollment: 64
Study Start Date: January 2007
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1- Arixtra Alone
Arixtra Alone
Drug: Arixtra alone
Arixtra subq injection 5mg dose (dose also dependent upon size and age of pt)
Other Name: Arixtra
Active Comparator: 2 Arixtra+ filter
Arixtra + filter
Device: Arixtra + filter
Arixtra as daily injections similar to arm I and placement of Inferior Vena Cava (IVC) filter.
Other Name: IVC filter and Arixtra

Detailed Description:
The development of clots is a potentially deadly complication in many cancer patients. The current optimal treatment is unknown. Evidence supporting the effectiveness of the use of Inferior Vena Caval Filters is lacking. This study will compare the two standard of care treatment options: anticoagulation with or without an inferior vena cava filter. The anticoagulation medication chosen will be Arixtra and it will be given once a day as an injection. Patients will be called at various intervals to monitor their signs and symptoms of new thromboembolisms. Patients will be equally randomized to receive either Arixtra with or without placement of an Inferior Vena Cava (IVC) filter. Fifty three patients are expected to be enrolled in each arm. Patients will be monitored for 90 days after study enrollment. Monitoring will include telephone calls and physician visits and repeat radiologists if the patient is symptomatic of a Deep Vein thrombosis (DVT). This will also include completion of a quality of life questionnaire.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Documentation of cancer.
  • The disease may be a solid tumor, Lymphoma or Multiple Myeloma. Pathology reports will be documented in the patient's chart and included in the data.
  • Age > 18 years
  • An acute, radiographically confirmed, de novo Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE)
  • No past medical history of a prior thrombus or known thrombophilia

Exclusion Criteria

  • Patients are not eligible for this study if they receive therapeutic doses of any heparin for more than 72 hours before randomization 31.
  • Already receiving oral anticoagulant therapy 31.
  • Severe renal impairment, calculated using the Cockcroft-Gault formula, defined as a creatinine clearance <30 mL/min 31.
  • Platelet count of less than 50,000 per cubic millimeter
  • Bleeding from the gastrointestinal tract that requires blood transfusion (s), intracranial bleeding or retroperitoneal bleeding.
  • An indication for thrombolysis
  • Allergy to iodine
  • Hereditary thrombophilia
  • Pregnancy
  • Likelihood of noncompliance
  • It is contraindicated to anticoagulate patients with brain metastasis secondary to melanoma, choriocarcinoma, renal cell and medullary thyroid carcinoma. If these patients have a Venous Thromboembolism (VTE), it is standard of care for these patients to have a CT of their head to evaluate if there is metastasis to the brain before they are anticoagulated 38. If these patients do have brain metastasis, they will not be included in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423683

Locations
United States, New York
North Shore University Hospital
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
GlaxoSmithKline
Investigators
Principal Investigator: Myra Barginear, MD North Shore University Hospital Monter Cancer Center
Principal Investigator: Daniel R. Budman, MD North Shore University Hospital Monter Cancer Center
  More Information

Responsible Party: Daniel Budman, Interim Chief, Division of Oncology, Northwell Health
ClinicalTrials.gov Identifier: NCT00423683     History of Changes
Other Study ID Numbers: IRB # 06-034 
Study First Received: January 17, 2007
Results First Received: October 24, 2012
Last Updated: May 6, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Northwell Health:
Cancer
thromboembolism

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fondaparinux
PENTA
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 23, 2016