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
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 44
Healthy volunteers: no

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.

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

Interventions: intervention 1: fondaparinux sodium
Intervention descriptions: intervention 1: Fondaparinux, 2.5 mg subcutaneous, Days 1-28 by mouth.

Protocol document: