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

NCT ID: NCT00423683

Last Updated: 2016-06-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2010-11-30

Brief Summary

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.

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.

Conditions

Cancer; Thromboembolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1- Arixtra Alone

Arixtra Alone

Group Type: EXPERIMENTAL

Arixtra alone

Intervention Type: DRUG

Arixtra subq injection 5mg dose (dose also dependent upon size and age of pt)

2 Arixtra+ filter

Arixtra + filter

Group Type: ACTIVE_COMPARATOR

Arixtra + filter

Intervention Type: DEVICE

Arixtra as daily injections similar to arm I and placement of Inferior Vena Cava (IVC) filter.

Interventions

Arixtra alone

Arixtra subq injection 5mg dose (dose also dependent upon size and age of pt)

Intervention Type: DRUG

Arixtra + filter

Arixtra as daily injections similar to arm I and placement of Inferior Vena Cava (IVC) filter.

Intervention Type: DEVICE

Other Intervention Names

Arixtra; IVC filter and Arixtra

Eligibility 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.

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

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Daniel Budman

Interim Chief, Division of Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Myra Barginear, MD

Role: PRINCIPAL_INVESTIGATOR

North Shore University Hospital Monter Cancer Center

Daniel R. Budman, MD

Role: PRINCIPAL_INVESTIGATOR

North Shore University Hospital Monter Cancer Center

Locations

North Shore University Hospital

Manhasset, New York, United States

Countries

United States

Other Identifiers

IRB # 06-034

Identifier Type: -

Identifier Source: org_study_id