Women's Cancer Center Protocol #45: Prolonged Venous Thromboembolism Prophylaxis With Fondaparinux in Gynecologic Oncology Patients: An Open Label Phase II Trial
18 Years
N/A
Female
Cervical Cancer, Endometrial Cancer, Fallopian Tube Cancer, Ovarian Cancer, Sarcoma, Thromboembolism, Vaginal Cancer, Vulvar Cancer
Trial Information
Women's Cancer Center Protocol #45: Prolonged Venous Thromboembolism Prophylaxis With Fondaparinux in Gynecologic Oncology Patients: An Open Label Phase II Trial
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.
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not part of normal medical care, with the understanding that consent may be withdrawn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:
Interventional
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:
No
Principal Investigator
Levi S. Downs, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Masonic Cancer Center, University of Minnesota
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000503985
NCT ID:
NCT00381888
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
Name | Location |
|---|---|
| Masonic Cancer Center at University of Minnesota | Minneapolis, Minnesota 55455 |
| Crozer-Chester Medical Center | Upland, Pennsylvania 19013 |
