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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ovarian Cancer, Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Sarcoma, Thromboembolism, Vaginal Cancer, Vulvar Cancer

Intervention / Treatment
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* Drug: fondaparinux sodium


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients Treated with Fondaparinux<br>Patients treated with at least one dose of Fondaparinux (2.5 mg subcutaneous, Days 1-28 by mouth). | Drug: fondaparinux sodium<br>* Fondaparinux, 2.5 mg subcutaneous, Days 1-28 by mouth.<br>* Other names: Artixtra(R);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With Venous Thromboembolism at Week 4 | Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system. | Week 4 (Days 28-35) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4. | This is a count of patients who did not have a clot (thromboembolism) occur during the 4 weeks of study - attributed to the use of Fondaparinux (study dry). Prophylaxis is a measure taken for the prevention of a disease or condition. | Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thromboembolism, cervical cancer, endometrial cancer, ovarian epithelial cancer, ovarian germ cell tumor, borderline ovarian surface epithelial-stromal tumor, ovarian sarcoma, ovarian stromal cancer, uterine sarcoma, vaginal cancer, vulvar cancer, fallopian tube cancer