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

NCT00423683 | Terminated Phase 3 Results DMC

• 1 other identifier: IRB # 06-034
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Thromboembolism

Keywords

Cancer; thromboembolism

Outcome Measures

Primary Outcomes (1)

• Adverse Outcomes

  Rates of VCF complications, bleeding, and recurrent or residual DVTs or PEs

  3 years or until death

Secondary Outcomes (3)

• Overall Survival

  3 years or until death

• Resolution of DVT

  3 years or until death

• Resolution of PE

  3 years or until death

Study Arms (2)

1- Arixtra Alone

EXPERIMENTAL

Arixtra Alone

Drug: Arixtra alone

2 Arixtra+ filter

ACTIVE COMPARATOR

Arixtra + filter

Device: Arixtra + filter

Interventions

Arixtra alone DRUG

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

Also known as: Arixtra

1- Arixtra Alone

Arixtra + filter DEVICE

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

Also known as: IVC filter and Arixtra

2 Arixtra+ filter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwell Health: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

MeSH Terms

Conditions

Neoplasms; Thromboembolism

Interventions

Fondaparinux

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Valerie Blake
• Organization: North Shore LIJ Health System

vblake@nshs.edu

516-562-0100

Study Officials

• Myra Barginear, MD

  North Shore University Hospital Monter Cancer Center

  PRINCIPAL INVESTIGATOR

• Daniel R. Budman, MD

  North Shore University Hospital Monter Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Interim Chief, Division of Oncology

Study Record Dates

• First Submitted: January 17, 2007
• First Posted: January 18, 2007
• Study Start: January 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 8, 2016
• Results First Posted: May 3, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)