Working… Menu
Trial record 14 of 33 for:    Vagina Sarcoma

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00381888
Recruitment Status : Completed
First Posted : September 28, 2006
Results First Posted : January 27, 2010
Last Update Posted : December 28, 2017
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Brief 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.

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

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
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
Study Start Date : January 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00381888

Layout table for location information
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
Layout table for investigator information
Principal Investigator: Levi S. Downs, MD Masonic Cancer Center, University of Minnesota

Layout table for additonal 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 )
First Posted: September 28, 2006    Key Record Dates
Results First Posted: January 27, 2010
Last Update Posted: December 28, 2017
Last Verified: December 2017
Keywords provided by Masonic Cancer Center, University of Minnesota:
ovarian sarcoma
uterine sarcoma
vaginal cancer
cervical cancer
endometrial cancer
ovarian epithelial cancer
ovarian germ cell tumor
borderline ovarian surface epithelial-stromal tumor
ovarian stromal cancer
vulvar cancer
fallopian tube cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Vaginal Neoplasms
Vaginal Diseases
Uterine Cervical Neoplasms
Endometrial Neoplasms
Fallopian Tube Neoplasms
Vulvar Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms by Site
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fallopian Tube Diseases
Vulvar Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors