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not part of normal medical care, with the understanding that consent may be withdrawn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