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

Masonic Cancer Center, University of Minnesota44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cervical Cancer Endometrial Cancer Fallopian Tube Cancer

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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

Outcomes

Primary Outcomes

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.

Time frame: Week 4 (Days 28-35)

Secondary Outcomes

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.

Time frame: Week 4