Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Heart and Blood Diseases

Gland and Hormone Related Diseases

Rare Diseases

Uterine Cervical Neoplasms

Thrombosis

Sarcoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Vaginal Neoplasms

Vulvar Neoplasms

Thromboembolism

Venous Thromboembolism

Brenner Tumor

Endometrial Neoplasms

Fallopian Tube Neoplasms

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Embolism

Embolism and Thrombosis

Vascular Diseases

Fallopian Tube Diseases

Vulvar Diseases

Vaginal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Soft Tissue Sarcoma

Vaginal Cancer

Germ Cells Tumors

Fallopian Tube Cancer

Vulvar Cancer

Ovarian Germ Cell Tumor

Uterine Sarcoma

Ovarian Low Malignant Potential Tumor

Fibrinolytic Agents

Anticoagulants

All Drugs and Chemicals

Anti-Infective Agents

Amino Acids

PENTA

Fondaparinux

Factor Xa Inhibitors

Antithrombins

Antithrombin III

Protease Inhibitors

Serine Proteinase Inhibitors

HIV Protease Inhibitors

Enzyme Inhibitors

Serine

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

Fondaparinux, 2.5 mg subcutaneous, Days 1-28 by mouth.

fondaparinux sodium

Levi S. Downs, MD

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.

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.

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

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

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

This is a count of patients who did not have a clot (thromboembolism) occur during the 4 weeks of study - attributed to the use of Fondaparinux (study dry). Prophylaxis is a measure taken for the prevention of a disease or condition.

Masonic Cancer Center, University of Minnesota

33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.

This number includes all patients that received one or more doses of study drug. All events were determined to be unrelated to Fondaparinux.

All Patients Who Received at Least One Dose of Fondaparinux

This number includes all patients that were consented and enrolled in the study and received at least one dose of study drug.

Patients Enrolled and Consented

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Levi S. Downs, Jr., M.D.

This number includes all patients that completed 4 weeks of the study and were treated with 2.5 mg of Fondaparinux on days 1-28.

Fondaparinux Patients Who Completed Study

The number includes those patients who completed the study and are evaluable for this outcome measure.

Number of Patients With Venous Thromboembolism at Week 4

These patients completed the study and are considered evaluable for this outcome measure.

Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4.

This number includes all patients consented and enrolled in this study.

Overall Study

Spots Global Cancer Trial Database for fondaparinux sodium