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

This study has been completed.
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota Identifier:
First received: September 26, 2006
Last updated: November 6, 2012
Last verified: November 2012

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.

Condition Intervention Phase
Cervical Cancer Endometrial Cancer Fallopian Tube Cancer Ovarian Cancer Sarcoma Thromboembolism Vaginal Cancer Vulvar Cancer Drug: fondaparinux sodium Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Women's Cancer Center Protocol #45: Prolonged Venous Thromboembolism Prophylaxis With Fondaparinux in Gynecologic Oncology Patients: An Open Label Phase II Trial

Resource links provided by NLM:

Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • Number of Patients With Venous Thromboembolism at Week 4 [ Time Frame: Week 4 (Days 28-35) ]
    Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system.

Secondary Outcome Measures:
  • Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4. [ Time Frame: 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.

Enrollment: 44
Study Start Date: January 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients Treated with Fondaparinux
Patients treated with at least one dose of Fondaparinux (2.5 mg subcutaneous, Days 1-28 by mouth).
Drug: fondaparinux sodium
Fondaparinux, 2.5 mg subcutaneous, Days 1-28 by mouth.
Other Name: Artixtra(R)

Detailed Description:



  • Evaluate the efficacy of prolonged (4 weeks) fondaparinux sodium administration in venous thromboembolism prophylaxis in patients undergoing gynecologic oncology surgery.


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00381888

United States, Minnesota
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Pennsylvania
Crozer-Chester Medical Center
Upland, Pennsylvania, United States, 19013
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Principal Investigator: Levi S. Downs, MD Masonic Cancer Center, University of Minnesota
  More Information

Responsible Party: Masonic Cancer Center, University of Minnesota Identifier: NCT00381888     History of Changes
Other Study ID Numbers: CDR0000503985
UMN-2006LS009 ( Other Identifier: Clinical Trials Office, University of Minnesota )
UMN-0603M82707 ( Other Identifier: IRB, University of Minnesota )
Study First Received: September 26, 2006
Results First Received: October 29, 2009
Last Updated: November 6, 2012

Keywords provided by Masonic Cancer Center, University of Minnesota:
cervical cancer
endometrial cancer
ovarian epithelial cancer
ovarian germ cell tumor
borderline ovarian surface epithelial-stromal tumor
ovarian stromal cancer
vaginal cancer
vulvar cancer
fallopian tube cancer
ovarian sarcoma
uterine sarcoma

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Fallopian Tube Neoplasms
Endometrial Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Vulvar Diseases
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fallopian Tube Diseases
Adnexal Diseases
Vaginal Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action processed this record on September 19, 2017