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

NCT00381888 | Completed Phase 2 Results DMC

• 3 other identifiers: CDR0000503985UMN-2006LS009UMN-0603M82707
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Venous Thromboembolism at Week 4

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

  Week 4 (Days 28-35)

Secondary Outcomes (1)

• Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4.

  Week 4

Study Arms (1)

Patients Treated with Fondaparinux

EXPERIMENTAL

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

Drug: fondaparinux sodium

Interventions

fondaparinux sodium DRUG

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

Also known as: Artixtra(R)

Patients Treated with Fondaparinux

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (2)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Crozer-Chester Medical Center

Upland, Pennsylvania, 19013, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Fallopian Tube Neoplasms; Ovarian Neoplasms; Sarcoma; Thromboembolism; Vaginal Neoplasms; Vulvar Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Fondaparinux

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Fallopian Tube Diseases; Adnexal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Vaginal Diseases; Vulvar Diseases; Carcinoma; Neoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Levi S. Downs, Jr., M.D.
• Organization: Masonic Cancer Center, University of Minnesota

downs008@umn.edu

612-626-6628

Study Officials

• Levi S. Downs, MD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2006
• First Posted: September 28, 2006
• Study Start: January 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: December 28, 2017
• Results First Posted: January 27, 2010

Record last verified: 2017-12

Locations

US (2)