Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer
RATIONALE: Fondaparinux may help prevent blood clots from forming in patients who are undergoing surgery for gynecologic cancer.
PURPOSE: This phase II trial is studying how well fondaparinux works in preventing blood clots in patients undergoing surgery for gynecologic cancer.
Fallopian Tube Cancer
Drug: fondaparinux sodium
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Women's Cancer Center Protocol #45: Prolonged Venous Thromboembolism Prophylaxis With Fondaparinux in Gynecologic Oncology Patients: An Open Label Phase II Trial|
- Number of Patients With Venous Thromboembolism at Week 4 [ Time Frame: Week 4 (Days 28-35) ] [ Designated as safety issue: No ]Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system.
- Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4. [ Time Frame: Week 4 ] [ Designated as safety issue: No ]This is a count of patients who did not have a clot (thromboembolism) occur during the 4 weeks of study - attributed to the use of Fondaparinux (study dry). Prophylaxis is a measure taken for the prevention of a disease or condition.
|Study Start Date:||January 2007|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Experimental: Patients Treated with Fondaparinux
Patients treated with at least one dose of Fondaparinux (2.5 mg subcutaneous, Days 1-28 by mouth).
Drug: fondaparinux sodium
Fondaparinux, 2.5 mg subcutaneous, Days 1-28 by mouth.
Other Name: Artixtra(R)
- 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.
|United States, Minnesota|
|Masonic Cancer Center at University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|United States, Pennsylvania|
|Crozer-Chester Medical Center|
|Upland, Pennsylvania, United States, 19013|
|Principal Investigator:||Levi S. Downs, MD||Masonic Cancer Center, University of Minnesota|