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

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Masonic Cancer Center, University of Minnesota
• Treatments: Fondaparinux; PENTA

Criteria

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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