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

Phase 2

Completed

• Conditions: Thromboembolism; Vaginal Cancer; Fallopian Tube Cancer; Sarcoma; Ovarian Cancer; Endometrial Cancer; Vulvar Cancer; Cervical Cancer
• Interventions: Drug: fondaparinux sodium

• Registration Number: NCT00381888
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2006-09-26
• Study First Submitted QC: 2006-09-26
• Study First Posted: 2006-09-28
• Study Start: 2007-01
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Results First Submitted: 2009-10-29
• Results First Submitted QC: 2009-12-29
• Results First Posted: 2010-01-27
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-03
• Last Update Posted: 2017-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 44

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients Treated with Fondaparinux	fondaparinux sodium	Patients treated with at least one dose of Fondaparinux (2.5 mg subcutaneous, Days 1-28 by mouth).

Primary Outcome Measures

Name	Time	Method
Number of Patients With Venous Thromboembolism at Week 4	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

Name	Time	Method
Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4.	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.

Trial Locations

Locations (2)

Crozer-Chester Medical Center; 🇺🇸 Upland, Pennsylvania, United States

Masonic Cancer Center at University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States