Status:
COMPLETED
Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles
Lead Sponsor:
Beth Israel Deaconess Medical Center
Collaborating Sponsors:
Massachusetts General Hospital
North Shore Medical Center
Conditions:
Advanced Pancreatic, Colon, Lung, Gastric and Ovarian Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
The study was a randomized phase II trial to evaluate the cumulative incidence of VTE in cancer outpatients. At baseline, measurement of tissue factor-bearing microparticles (TFMP) was performed by im...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00908960
Start Date
May 1 2009
End Date
October 1 2012
Last Update
December 19 2017
Active Locations (5)
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1
University of Southern California-Keck School of Medicine
Los Angeles, California, United States, 90033
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
4
VA Boston Healthcare System
Boston, Massachusetts, United States, 02130