Clinical trial NCT00381888: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2006-09-28
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Patients With Venous Thromboembolism at Week 4
timeFrame: Week 4 (Days 28-35)
Secondary outcomes:
measure: Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4.
timeFrame: Week 4
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center at University of Minnesota
state: Minnesota
city: Upland
country: United States
facility: Crozer-Chester Medical Center
state: Pennsylvania
Study officials:
affiliation: Masonic Cancer Center, University of Minnesota
name: Levi S. Downs, MD
role: PRINCIPAL_INVESTIGATOR
References: