Spots Global Cancer Trial Database for Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer

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Trial Identification

Brief Title: Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer

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

Study ID: NCT00381888

Conditions

Cervical Cancer

Endometrial Cancer

Fallopian Tube Cancer

Interventions

fondaparinux sodium

Study Description

Brief 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.