CancerPhase 3NCT00423683

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

A Phase 3 study testing Arixtra alone and Arixtra + filter in people with Cancer and Thromboembolism, run by Northwell Health at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cancer, Thromboembolism
What is being tested?: Arixtra alone and Arixtra + filter
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteUnited States
Study dates: Jan 2007to Nov 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

North Shore University Hospital
Manhasset, New York, 11030

Other trials in United States

About this study

Official title: A Randomized Control Trial of Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With A Venous Thromboembolism

Read the 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
Being tested: Arixtra alone, Arixtra + filter
Keywords: Cancer, thromboembolism
Medical subject headings: Neoplasms, Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Arixtra aloneDrug
Also called Arixtra
Arixtra subq injection 5mg dose (dose also dependent upon size and age of pt)
Arixtra + filterDevice
Also called IVC filter and Arixtra
Arixtra as daily injections similar to arm I and placement of Inferior Vena Cava (IVC) filter.

Study groups in NCT00423683
Study group	Role	What they receive
1- Arixtra Alone	Experimental	Arixtra Alone Receives: Drug: Arixtra alone
2 Arixtra+ filter	Active comparator	Arixtra + filter Receives: Device: Arixtra + filter

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse Outcomes
Rates of VCF complications, bleeding, and recurrent or residual DVTs or PEs
Measured: 3 years or until death

Secondary outcomes (3)

Overall Survival
Measured: 3 years or until death
Resolution of DVT
Measured: 3 years or until death
Resolution of PE
Measured: 3 years or until death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Nov 2010

First posted18 Jan 2007 (estimated)
Study startJan 2007
Primary completionNov 2010
Study completionNov 2010

Why it stopped: Study accrual stopped due to poor accrual.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CancerStudies of the same condition, open and under way.
More trials run by Northwell HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00423683
Sponsor's protocol ID: IRB # 06-034
Status last verified: May 2016
First submitted: 17 Jan 2007
Last updated: 8 Jun 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Control Trial of Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With A Venous Thromboembolism
ClinicalTrials.gov ID: NCT00423683
Acronym / sponsor ID: IRB # 06-034
Conditions: Cancer, Thromboembolism
Keywords: Cancer, thromboembolism
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study accrual stopped due to poor accrual.
Enrolment: 64 participants (actual)
Lead sponsor: Northwell HealthUniversity, hospital or other
Collaborators: GlaxoSmithKline
Study start: Jan 2007
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 18 Jan 2007 (estimated)
Results: Posted 3 May 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1- Arixtra Alone	Experimental	Drug: Arixtra aloneArixtra Alone
2 Arixtra+ filter	Active comparator	Device: Arixtra + filterArixtra + filter

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Arixtra aloneAlso: ArixtraArixtra subq injection 5mg dose (dose also dependent upon size and age of pt)	Drug	1- Arixtra Alone
Arixtra + filterAlso: IVC filter and ArixtraArixtra as daily injections similar to arm I and placement of Inferior Vena Cava (IVC) filter.	Device	2 Arixtra+ filter

Primary outcome

Adverse Outcomes
Time frame: 3 years or until death
Rates of VCF complications, bleeding, and recurrent or residual DVTs or PEs

3 secondary outcomes

Overall Survival
Time frame: 3 years or until death
Resolution of DVT
Time frame: 3 years or until death
Resolution of PE
Time frame: 3 years or until death

Results and safety

Results posted to the registry on 3 May 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2 Arixtra+ Filter	31	30
1-Arixtra Alone	33	33

Primary outcome: Adverse Outcomes

Time frame: 3 years or until death. Number. Unit: percentage of participants

Measure	Arixtra n = 33	Arixtra and Filter n = 31
Value	15.2	16.1

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2 Arixtra+ Filter	0 of 31 (0%)	0 of 31 (0%)	Not reported
Arixtra Alone	0 of 33 (0%)	0 of 33 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
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Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Myra Barginear, MD principal investigator

North Shore University Hospital Monter Cancer Center

Daniel R. Budman, MD principal investigator

North Shore University Hospital Monter Cancer Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Arixtra alone and Arixtra + filter in people with Cancer and Thromboembolism, run by Northwell Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Outcomes (time frame: 3 years or until death). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00423683.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2016.