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Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles

Information source: Dana-Farber Cancer Institute
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Advanced Pancreatic, Colon, Lung, Gastric and Ovarian Cancer

Intervention: Enoxaparin (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Beth Israel Deaconess Medical Center

Official(s) and/or principal investigator(s):
Jeffrey Zwicker, MD, Principal Investigator, Affiliation: Beth Israel Deaconess Medical Center

Summary

Research studies have shown a strong association between cancer and blood clots in the veins (also known as deep vein thrombosis). These blood clots can flow to the lungs (pulmonary embolism) which in severe cases may be life threatening. The purpose of this research study is to see if enoxaparin is effective in preventing blood clots in the veins in participants who have cancer of the pancreas, colorectal, non-small cell lung, ovary, or gastric and also have high levels of tissue factor bearing microparticles in their blood (TFMP). TFMP are small particles that are generated from different types of blood cells in the body. In people who have cancer, TFMP are thought to be generated from cancer cells and may represent a risk factor for deep vein thrombosis. Enoxaparin has been used to prevent formation of blood clots in patients after abdominal or orthopedic surgery and in patients who suffer from a severe medical illness. Based on these studies, we are investigating to see if it prevents thrombosis in people with certain types of cancer.

Clinical Details

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

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

Primary outcome: The Cumulative Incidence of VTE at 2 Months.

Secondary outcome:

To Investigate the Safety of Prophylactic Enoxaparin in Cancer Patients (Major Bleeding Episodes).

To Assess the Impact of Enoxaparin on Overall Survival.

Detailed description:

- 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

University of Southern California-Keck School of Medicine, Los Angeles, California 90033, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02115, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

VA Boston Healthcare System, Boston, Massachusetts 02130, United States

Mass General/North Shore Cancer Center, Danvers, Massachusetts 01923, United States

Additional Information

Starting date: May 2009
Last updated: October 22, 2013

Page last updated: August 20, 2015

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