NCT00381888

Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer

Women's Cancer Center Protocol #45: Prolonged Venous Thromboembolism Prophylaxis With Fondaparinux in Gynecologic Oncology Patients: An Open Label Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Cervical Cancer
• Endometrial Cancer
• Fallopian Tube Cancer
• Ovarian Cancer
• Sarcoma
• Thromboembolism
• Vaginal Cancer
• Vulvar Cancer

Interventions

Type	Name	Description
DRUG	fondaparinux sodium	Fondaparinux, 2.5 mg subcutaneous, Days 1-28 by mouth.

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2006-09-28
• Last updated: 2017-12-28
• Results posted: 2010-01-27

Locations

2 sites across 1 country: United States