Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles (MicroTEC)
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.
Advanced Pancreatic, Colon, Lung, Gastric and Ovarian Cancer
|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|
- 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 ]
- 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 ]
|Study Start Date:||May 2009|
|Study Completion Date:||October 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Experimental: Arm A (high TFMP)
Enoxaparin given subcutaneously daily for 2 months
Given subcutaneously daily for 2 months
No Intervention: Arm B (high TFMP)
No Intervention: Arm C (low TFMP)
- 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.
|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|
|Principal Investigator:||Jeffrey Zwicker, MD||Beth Israel Deaconess Medical Center|