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

December 3, 2017 updated by: Masonic Cancer Center, University of Minnesota

Women's Cancer Center Protocol #45: Prolonged Venous Thromboembolism Prophylaxis With Fondaparinux in Gynecologic Oncology Patients: An Open Label Phase II Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Masonic Cancer Center at University of Minnesota
    • Pennsylvania
      • Upland, Pennsylvania, United States, 19013
        • Crozer-Chester Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Artixtra(R)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 4 (Days 28-35)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masonic Cancer Center, University of Minnesota

Investigators

  • Principal Investigator: Levi S. Downs, MD, Masonic Cancer Center, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

September 26, 2006

First Submitted That Met QC Criteria

September 26, 2006

First Posted (Estimate)

September 28, 2006

Study Record Updates

Last Update Posted (Actual)

December 28, 2017

Last Update Submitted That Met QC Criteria

December 3, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000503985
  • UMN-2006LS009 (Other Identifier: Clinical Trials Office, University of Minnesota)
  • UMN-0603M82707 (Other Identifier: IRB, University of Minnesota)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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