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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381888
• Other study ID #: CDR0000503985
• Secondary ID: UMN-2006LS009UMN
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2006
• Last updated: December 3, 2017
• Start date: January 2007
• Est. completion date: January 2009

Study information

• Verified date: December 2017
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Sarcoma
• Thromboembolism
• Uterine Cervical Neoplasms
• Vaginal Cancer
• Vaginal Neoplasms
• Vulvar Cancer
• Vulvar Neoplasms

Intervention

Drug:
• fondaparinux sodium
Fondaparinux, 2.5 mg subcutaneous, Days 1-28 by mouth.

Locations

Country	Name	City	State
United States	Masonic Cancer Center at University of Minnesota	Minneapolis	Minnesota
United States	Crozer-Chester Medical Center	Upland	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week 4 (Days 28-35)
Secondary	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.	Week 4