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

Phase 2
18 Years
Not Enrolling
Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Sarcoma, Thromboembolism, Vaginal Cancer, Vulvar Cancer

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Trial Information

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



- Evaluate the efficacy of prolonged (4 weeks) fondaparinux sodium administration in
venous thromboembolism prophylaxis in patients undergoing gynecologic oncology surgery.


- 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.

Inclusion 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not part of normal medical care, with the understanding that consent may be withdrawn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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients With Venous Thromboembolism at Week 4

Outcome Description:

Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system.

Outcome Time Frame:

Week 4 (Days 28-35)

Safety Issue:


Principal Investigator

Levi S. Downs, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

January 2007

Completion Date:

January 2009

Related Keywords:

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



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