Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles - Full Text View

Sponsor:	Beth Israel Deaconess Medical Center
Collaborators:	Massachusetts General Hospital North Shore Medical Center University of Southern California VA Boston Healthcare System Sanofi-Aventis
Information provided by (Responsible Party):	Jeffrey Zwicker, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00908960

Purpose

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.

Condition	Intervention	Phase
Advanced Pancreatic, Colon, Lung, Gastric and Ovarian Cancer	Drug: Enoxaparin	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	A Randomized Controlled Trial of Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Enoxaparin Sodium Thromboplastin

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

Assess the benefit of enoxaparin in preventing venous thromboembolic events in cancer patients with high levels of circulating tissue factor bearing microparticles (TFMP). [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To investigate the safety of prophylactic enoxaparin in cancer patients (major bleeding episodes). [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
To assess the impact of enoxaparin on overall survival. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
To investigate the cumulative incidence of symptomatic or proximal venous thromboembolic events (VTE) at 2 months. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
To investigate the cumulative incidence of total VTE in cancer patients with low TFMP compared with those with high TFMP not treated with enoxaparin. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
To assess the influence of chemotherapy or enoxaparin on TFMP levels [ Time Frame: 3 years ] [ Designated as safety issue: No ]
To assess the association between absolute TFMP levels and thrombotic risk [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	May 2009
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm A (high TFMP) Enoxaparin given subcutaneously daily for 2 months	Drug: Enoxaparin Given subcutaneously daily for 2 months
No Intervention: Arm B (high TFMP) Observation
No Intervention: Arm C (low TFMP) Observation

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

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908960

Locations

United States, California
University of Southern California-Keck School of Medicine
Los Angeles, California, United States, 90033
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
VA Boston Healthcare System
Boston, Massachusetts, United States, 02130
Mass General/North Shore Cancer Center
Danvers, Massachusetts, United States, 01923

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Massachusetts General Hospital

North Shore Medical Center

University of Southern California

VA Boston Healthcare System

Sanofi-Aventis

Investigators

Principal Investigator:

Jeffrey Zwicker, MD

Beth Israel Deaconess Medical Center

More Information

No publications provided

Responsible Party:	Jeffrey Zwicker, MD, Attending Physician, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00908960 History of Changes
Other Study ID Numbers:	08-378
Study First Received:	May 26, 2009
Last Updated:	February 3, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:

enoxaparin

Additional relevant MeSH terms:

Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Thromboplastin

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

ClinicalTrials.gov processed this record on February 09, 2012