Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer
NCT ID: NCT00381888
Last Updated: 2017-12-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2007-01-31
2009-01-31
Brief Summary
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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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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Patients Treated with Fondaparinux
Patients treated with at least one dose of Fondaparinux (2.5 mg subcutaneous, Days 1-28 by mouth).
fondaparinux sodium
Fondaparinux, 2.5 mg subcutaneous, Days 1-28 by mouth.
Interventions
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fondaparinux sodium
Fondaparinux, 2.5 mg subcutaneous, Days 1-28 by mouth.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Levi S. Downs, MD
Role: PRINCIPAL_INVESTIGATOR
Masonic Cancer Center, University of Minnesota
Locations
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Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States
Crozer-Chester Medical Center
Upland, Pennsylvania, United States
Countries
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Other Identifiers
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UMN-2006LS009
Identifier Type: OTHER
Identifier Source: secondary_id
UMN-0603M82707
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000503985
Identifier Type: -
Identifier Source: org_study_id