Phase 2 N=44 Treatment

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

Cervical Cancer · Endometrial Cancer · Fallopian Tube Cancer · Ovarian Cancer · Sarcoma

Bottom Line

View on ClinicalTrials.gov: NCT00381888 ↗

Enrolled (actual)

Serious AEs

21.2%

Results posted

Jan 2010

Primary outcome: Primary: Number of Patients With Venous Thromboembolism at Week 4 — 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: fondaparinux sodium (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Masonic Cancer Center, University of Minnesota
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Patients With Venous Thromboembolism at Week 4	—	—
SECONDARY Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4.	27	—

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.

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00381888). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.