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A Randomized Controlled Trial of Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles


Phase 2
18 Years
N/A
Not Enrolling
Both
Advanced Pancreatic, Colon, Lung, Gastric and Ovarian Cancer

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Trial Information

A Randomized Controlled Trial of Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles


- Because no one knows which of the study options is best, participants will be
randomized into one of the following study groups. Participants who have high levels
of TFMP in their blood will be in one of the two arms indicated.

- Arm A (High TFMP): Enoxaparin given subcutaneously (into the skin) daily for 2 months,
and lower extremity ultrasound performed at 2 months.

- Arm B (High TFMP): Observation, lower extremity ultrasound performed at 2 months.

- Arm C (Low TFMP): Observation, lower extremity ultrasound performed at 2 months.

- At 2 months, participants will have a physical examination and will be asked questions
about their general health and specific questions about any problems they might be
having. They will also have a lower extremity ultrasound and blood tests performed at
2 months.


Inclusion Criteria:



- Histologically confirmed malignancy that is metastatic or unresectable and for which
standard curative therapies do not exist. Eligible malignancies include:

- Adenocarcinoma of the pancreas (locally advanced or metastatic)

- Colorectal (stage IV)

- Non-small cell lung (unresectable stage III or IV)

- Relapsed ovarian or stage IV

- Surgically unresectable or metastatic gastric adenocarcinoma

- First or second line therapy (within 4 weeks of initiating therapy).

- Minimum age 18 years

- Life expectancy of greater than 6 months

- ECOG Performance Status 0, 1, or 2 (Karnofsky 60% or greater).

- Participants must have normal organ and marrow function as outlined in the protocol.

Exclusion Criteria:

- Participants may not be receiving any other study agents.

- Known brain metastases should be excluded from this clinical trial because of their
poor prognosis and higher potential for intracranial hemorrhage.

- Prior history of documented venous thromboembolic event or pulmonary embolism within
the last 5 years years (excluding central line associated events whereby patients
completed anticoagulation > 3 months previously)

- Active bleeding or high risk for bleeding (e.g. known acute gastrointestinal ulcer)

- Any history of significant hemorrhage (requiring hospitalization or transfusion)
outside of a surgical setting within the last 5 years

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to enoxaparin or heparin.

- History of heparin-induced thrombocytopenia

- Presence of coagulopathy (PT or PTT> 1.5 x upper limit of normal)

- Familial bleeding diathesis

- Known diagnosis of disseminated intravascular coagulation

- Currently receiving anticoagulant therapy

- Current use of aspirin (>81mg daily), Clopidogrel (Plavix), cilostazol (Pletal),
aspirin-dipyridamole (Aggrenox), or regular use of non-steroidal anti-inflammatory
agents more than twice weekly. Maximum dose of ibuprofen is 400mg no more than twice
per week.

- Uncontrolled intercurrent illness including, but not limited to, ongoing active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Assess the benefit of enoxaparin in preventing venous thromboembolic events in cancer patients with high levels of circulating tissue factor bearing microparticles (TFMP).

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Jeffrey Zwicker, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

08-378

NCT ID:

NCT00908960

Start Date:

May 2009

Completion Date:

October 2012

Related Keywords:

  • Advanced Pancreatic, Colon, Lung, Gastric and Ovarian Cancer
  • enoxaparin
  • Ovarian Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Massachusetts General HospitalBoston, Massachusetts  02114-2617
University of Southern California-Keck School of MedicineLos Angeles, California  90033
VA Boston Healthcare SystemBoston, Massachusetts  02130
Mass General/North Shore Cancer CenterDanvers, Massachusetts  01923