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

Primary Purpose

Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
fondaparinux sodium
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Cancer focused on measuring thromboembolism, cervical cancer, endometrial cancer, ovarian epithelial cancer, ovarian germ cell tumor, borderline ovarian surface epithelial-stromal tumor, ovarian sarcoma, ovarian stromal cancer, uterine sarcoma, vaginal cancer, vulvar cancer, fallopian tube cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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

Sites / Locations

  • Masonic Cancer Center at University of Minnesota
  • Crozer-Chester Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients Treated with Fondaparinux

Arm Description

Patients treated with at least one dose of Fondaparinux (2.5 mg subcutaneous, Days 1-28 by mouth).

Outcomes

Primary Outcome Measures

Number of Patients With Venous Thromboembolism at Week 4
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.
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.

Full Information

First Posted
September 26, 2006
Last Updated
December 3, 2017
Sponsor
Masonic Cancer Center, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT00381888
Brief Title
Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Sarcoma, Thromboembolism, Vaginal Cancer, Vulvar Cancer
Keywords
thromboembolism, cervical cancer, endometrial cancer, ovarian epithelial cancer, ovarian germ cell tumor, borderline ovarian surface epithelial-stromal tumor, ovarian sarcoma, ovarian stromal cancer, uterine sarcoma, vaginal cancer, vulvar cancer, fallopian tube cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients Treated with Fondaparinux
Arm Type
Experimental
Arm Description
Patients treated with at least one dose of Fondaparinux (2.5 mg subcutaneous, Days 1-28 by mouth).
Intervention Type
Drug
Intervention Name(s)
fondaparinux sodium
Other Intervention Name(s)
Artixtra(R)
Intervention Description
Fondaparinux, 2.5 mg subcutaneous, Days 1-28 by mouth.
Primary Outcome Measure Information:
Title
Number of Patients With Venous Thromboembolism at Week 4
Description
Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system.
Time Frame
Week 4 (Days 28-35)
Secondary Outcome Measure Information:
Title
Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4.
Description
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.
Time Frame
Week 4

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Levi S. Downs, MD
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masonic Cancer Center at University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Crozer-Chester Medical Center
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States

12. IPD Sharing Statement

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

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