Women's Cancer Center Protocol #45: Prolonged Venous Thromboembolism Prophylaxis With Fondaparinux in Gynecologic Oncology Patients: An Open Label Phase II Trial
- Evaluate the efficacy of prolonged (4 weeks) fondaparinux sodium administration in
venous thromboembolism prophylaxis in patients undergoing gynecologic oncology surgery.
- Evaluate the safety of this regimen in these patients (4 weeks).
- Determine the feasibility of this regimen in these patients (4 weeks).
OUTLINE: This is an open-label study.
Beginning after surgery, patients receive fondaparinux sodium subcutaneously once daily on
days 1-28 in the absence of disease progression or unacceptable toxicity. Patients undergo
duplex ultrasonography of the lower extremities between day 28-35.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients With Venous Thromboembolism at Week 4
Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system.
Week 4 (Days 28-35)
Levi S. Downs, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center at University of Minnesota||Minneapolis, Minnesota 55455|
|Crozer-Chester Medical Center||Upland, Pennsylvania 19013|