Cancer, Thromboembolism
Conditions
Keywords
Cancer, thromboembolism
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.
Interventions
DRUGArixtra alone
Arixtra subq injection 5mg dose (dose also dependent upon size and age of pt)
DEVICEArixtra + filter
Arixtra as daily injections similar to arm I and placement of Inferior Vena Cava (IVC) filter.
Sponsors
GlaxoSmithKline
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Outcomes | 3 years or until death | Rates of VCF complications, bleeding, and recurrent or residual DVTs or PEs |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | 3 years or until death |
| Resolution of DVT | 3 years or until death |
| Resolution of PE | 3 years or until death |
Countries
United States
Participant flow
Recruitment details
recruitment was slowed due to newly approved medications so study was stopped early.
Participants by arm
| Arm | Count |
|---|---|
| 2 Arixtra+ Filter Arixtra subq injection + IVC filter | 31 |
| 1- Arixtra Alone Arixtra treatment without inferior vena cava filter | 33 |
| Total | 64 |
Baseline characteristics
| Characteristic | 1- Arixtra Alone | 2 Arixtra+ Filter | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 21 Participants | 10 Participants | 31 Participants |
| Age, Categorical Between 18 and 65 years | 12 Participants | 21 Participants | 33 Participants |
| Age, Continuous | 67 years STANDARD_DEVIATION 14 | 63 years STANDARD_DEVIATION 2 | 65 years STANDARD_DEVIATION 13 |
| Region of Enrollment United States | 33 participants | 31 participants | 64 participants |
| Sex: Female, Male Female | 24 Participants | 16 Participants | 40 Participants |
| Sex: Female, Male Male | 9 Participants | 15 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 0 / 33 |
| serious Total, serious adverse events | 0 / 31 | 0 / 33 |
Outcome results
Primary
Adverse Outcomes
Rates of VCF complications, bleeding, and recurrent or residual DVTs or PEs
Time frame: 3 years or until death
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arixtra | Adverse Outcomes | 15.2 percentage of participants |
| Arixtra and Filter | Adverse Outcomes | 16.1 percentage of participants |
Secondary
Overall Survival
Time frame: 3 years or until death
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Arixtra | Overall Survival | 493 days |
| Arixtra and Filter | Overall Survival | 266 days |
Secondary
Resolution of DVT
Time frame: 3 years or until death
Population: 33 participants contributed 59 DVT sites in Arm 1; 31 participants contributed 48 DVT sites in Arm 2. Unit of analysis was DVT sites
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arixtra | Resolution of DVT | 61.0 percentage of DVT sites |
| Arixtra and Filter | Resolution of DVT | 37.5 percentage of DVT sites |
Secondary
Resolution of PE
Time frame: 3 years or until death
Population: 33 participants contributed 25 PE sites in Arm 1; 31 participants contributed 18 PE sites in Arm 2. Unit of analysis was PE sites
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arixtra | Resolution of PE | 32.0 percentage of PE sites |
| Arixtra and Filter | Resolution of PE | 66.7 percentage of PE sites |