Women's Cancer Center Protocol #45: Prolonged Venous Thromboembolism Prophylaxis With Fondaparinux in Gynecologic Oncology Patients: An Open Label Phase II Trial
Women's Cancer Center Protocol #45: Prolonged Venous Thromboembolism Prophylaxis With Fondaparinux in Gynecologic Oncology Patients: An Open Label Phase II Trial
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
Secondary
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:
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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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