Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer
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.
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 not part of normal medical care, with the understanding that consent may be withdrawn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