Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With a Venous Thromboembolism - Full Text View

Sponsor:	North Shore Long Island Jewish Health System
Collaborator:	GlaxoSmithKline
Information provided by:	North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:	NCT00423683

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 Device: Inferior Vena Cava Filter (with or without) Drug: Arixtra alone Device: Arixtra + filter	Phase III

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:

MedlinePlus related topics: Cancer

Drug Information available for: ORG 31540 Fondaparinux sodium

U.S. FDA Resources

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:

Death due to any cause, event free survival. [ Time Frame: One year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Occurrence of pulmonary embolism, [ Time Frame: One year ] [ Designated as safety issue: Yes ]
major bleeding, thrombophlebitis, [ Time Frame: One year ] [ Designated as safety issue: Yes ]
cellulitis secondary to IV filter, [ Time Frame: One year ] [ Designated as safety issue: Yes ]
thrombosis of the IVC filter and quality of life. [ Time Frame: One year ] [ 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 Arixtra Other Name: Arixtra alone as subq injection - dose dependent upon age and size of pt. 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: Inferior Vena Cava Filter (with or without) IVC filter - filter of choice by radiologist Other Name: IVC filter Device: Arixtra + filter Atrixa as daily injections similar to arm I and placement of IVC filter. Other Name: IVC filter and Arixtra Device: Arixtra + filter Arixtra subq injection + IVC filter Other Name: Arixtra as subq injection dose dependent upon age and size of pt. Plus placement of IVC filter

Arms

Assigned Interventions

Experimental: 1- Arixtra Alone

Arixtra Alone

Drug: Arixtra

Arixtra

Other Name: Arixtra alone as subq injection - dose dependent upon age and size of pt.

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: Inferior Vena Cava Filter (with or without)

IVC filter - filter of choice by radiologist

Other Name: IVC filter

Device: Arixtra + filter

Atrixa as daily injections similar to arm I and placement of IVC filter.

Other Name: IVC filter and Arixtra

Device: Arixtra + filter

Arixtra subq injection + IVC filter

Other Name: Arixtra as subq injection dose dependent upon age and size of pt. Plus placement of IVC filter

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 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 DVT. This will also include completion of a quality of life questionnaire.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Cancer patient, over 18 years of age, acute radiographically confirmed denovo DVT or PE.

Contacts and Locations

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

Locations

United States, New York
North Shore University Hospital, Monter Cancer Center
Lake Success, New York, United States, 11042
North Shore University Hospital
Manhasset, New York, United States, 11030

Sponsors and Collaborators

North Shore Long Island Jewish Health System

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

No publications provided

Responsible Party:	Daniel R. Budman, MD, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:	NCT00423683 History of Changes
Other Study ID Numbers:	IRB # 06-034
Study First Received:	January 17, 2007
Last Updated:	November 1, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by North Shore Long Island Jewish Health System:

Cancer
thromboembolism

Additional relevant MeSH terms:

Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Fondaparinux
PENTA

Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 12, 2012