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

University of Minnesota (UMN)

Status and phase: Completed; Phase 2

Conditions: Endometrial Cancer; Thromboembolism; Sarcoma; Vulvar Cancer; Vaginal Cancer; Fallopian Tube Cancer; Ovarian Cancer; Cervical Cancer

Treatments: Drug: fondaparinux sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT00381888

UMN-0603M82707 (Other Identifier)

CDR0000503985

UMN-2006LS009 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 1 patient group

Patients Treated with Fondaparinux

Experimental group

Description:

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

Treatment:

Drug: fondaparinux sodium