Clinical Trial: Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Women's Cancer Center Protocol #45: Prolonged Venous Thromboembolism Prophylaxis With Fondaparinux in Gynecologic Oncology Patients: An Open Label Phase II Trial
Brief Summary:
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.
Detailed Summary:
OBJECTIVES:
Primary
- Evaluate the efficacy of prolonged (4 weeks) fondaparinux sodium administration in venous thromboembolism prophylaxis in patients undergoing gynecologic oncology surgery.
Secondary
- 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.
Sponsor: Masonic Cancer Center, University of Minnesota
Current Primary Outcome: Number of Patients With Venous Thromboembolism at Week 4 [ Time Frame: Week 4 (Days 28-35) ]
Original Primary Outcome:
Current Secondary Outcome: Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4. [ Time Frame: Week 4 ]
Original Secondary Outcome:
Information By: Masonic Cancer Center, University of Minnesota
Dates:
Date Received: September 26, 2006
Date Started: January 2007
Date Completion:
Last Updated: November 6, 2012
Last Verified: November 2012