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

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.

Inclusion criteria

• Scheduled to undergo major, open abdominal-pelvic surgery for known or presumed gynecologic malignancy
• Age 18 years or older at the time of signing the consent
• Gynecologic Oncology Group (GOG) performance status of ≤ 2
• Life expectancy of > 3 months
• Patient's weight must be ≥ 50 kg
• Adequate organ function within 28 days of study entry defined as:

• Hemoglobin ≥ 9.0 g/dL
• Platelet ≥ 100,000 x 109/L
• Blood urea nitrogen (BUN) ≤ 30 mg/dL
• Serum creatinine ≤ 1.5 mg/dL
• Not pregnant as determined by a negative urine or serum pregnancy test within 14 days of study enrollment
• Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion criteria

• Current treatment with anticoagulants
• Thromboembolism within the previous 6 months
• Bleeding/blood disorders (e.g., thrombocytopenia), gastrointestinal bleeding (e.g., active ulcers), history of stroke within past 3 years, or severe and currently uncontrolled high blood pressure
• Bacterial endocarditis
• Known hypersensitivity to fondaparinux sodium