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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier:
NCT00381888
First received: September 26, 2006
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00381888

Locations
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
Investigators
Principal Investigator: Levi S. Downs, MD Masonic Cancer Center, University of Minnesota
  More Information

Additional Information:
No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00381888     History of Changes
Other Study ID Numbers: CDR0000503985, UMN-2006LS009, UMN-0603M82707
Study First Received: September 26, 2006
Results First Received: October 29, 2009
Last Updated: November 6, 2012
Health Authority: United States: Food and Drug Administration

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
thromboembolism
ovarian sarcoma
uterine sarcoma

Additional relevant MeSH terms:
Ovarian Neoplasms
Uterine Cervical Neoplasms
Fallopian Tube Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Neoplasms
Vaginal Diseases
Sarcoma
Thromboembolism
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Uterine Cervical Diseases
Uterine Diseases
Fallopian Tube Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Vulvar Diseases
Fondaparinux

ClinicalTrials.gov processed this record on September 18, 2014