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Spots Global Cancer Trial Database for Ixabepilone in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Previously Treated With Chemotherapy

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Trial Identification

Brief Title: Ixabepilone in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Previously Treated With Chemotherapy

Official Title: A Phase II Evaluation of Ixabepilone (NSC #710428) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus

Study ID: NCT01220609

Study Description

Brief Summary: This phase II trial is studying the side effects and how well ixabepilone works in treating patients with recurrent or persistent leiomyosarcoma of the uterus previously treated with chemotherapy. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed Description: PRIMARY OBJECTIVES: I. To determine the response rate (complete and partial responses by RECIST 1.1) of ixabepilone in patients with recurrent or persistent leiomyosarcoma of the uterus who have failed one previous chemotherapy regimen. II. To determine the nature and degree of toxicity of ixabepilone as assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4 in this cohort of patients. SECONDARY OBJECTIVES: I. To determine the duration of progression-free survival (PFS) and overall survival (OS). II. To determine the level of beta-III tubulin expression measured by IHC in women with leiomyosarcoma. III. To determine if beta-III tubulin expression as measured by IHC predicts response to ixabepilone in women with leiomyosarcoma. OUTLINE: Patients receive ixabepilone intravenously (IV) over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Gynecologic Oncology Group of Arizona, Phoenix, Arizona, United States

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Los Angeles County-USC Medical Center, Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

University of Colorado Cancer Center - Anschutz Cancer Pavilion, Aurora, Colorado, United States

Hartford Hospital, Hartford, Connecticut, United States

Saint Francis Hospital and Medical Center, Hartford, Connecticut, United States

The Hospital of Central Connecticut, New Britain, Connecticut, United States

Florida Gynecologic Oncology, Fort Myers, Florida, United States

John B Amos Cancer Center, Columbus, Georgia, United States

Saint Alphonsus Cancer Care Center-Boise, Boise, Idaho, United States

Rush University Medical Center, Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

Sudarshan K Sharma MD Limted-Gynecologic Oncology, Hinsdale, Illinois, United States

Advocate Christ Medical Center, Oak Lawn, Illinois, United States

Cadence Cancer Center in Warrenville, Warrenville, Illinois, United States

Saint Vincent Oncology Center, Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

Greater Baltimore Medical Center, Baltimore, Maryland, United States

Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States

Michigan Cancer Research Consortium Community Clinical Oncology Program, Ann Arbor, Michigan, United States

Oakwood Hospital and Medical Center, Dearborn, Michigan, United States

Henry Ford Hospital, Detroit, Michigan, United States

Saint John Hospital and Medical Center, Detroit, Michigan, United States

Hurley Medical Center, Flint, Michigan, United States

Genesys Regional Medical Center-West Flint Campus, Flint, Michigan, United States

Allegiance Health, Jackson, Michigan, United States

Borgess Medical Center, Kalamazoo, Michigan, United States

Bronson Methodist Hospital, Kalamazoo, Michigan, United States

West Michigan Cancer Center, Kalamazoo, Michigan, United States

Sparrow Hospital, Lansing, Michigan, United States

Saint Mary Mercy Hospital, Livonia, Michigan, United States

Saint Joseph Mercy Oakland, Pontiac, Michigan, United States

Saint Joseph Mercy Port Huron, Port Huron, Michigan, United States

Saint Mary's of Michigan, Saginaw, Michigan, United States

Saint John Macomb-Oakland Hospital, Warren, Michigan, United States

Singing River Hospital, Pascagoula, Mississippi, United States

Phelps County Regional Medical Center, Rolla, Missouri, United States

Saint John's Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, United States

Washington University School of Medicine, Saint Louis, Missouri, United States

Mercy Hospital Springfield, Springfield, Missouri, United States

Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield, Springfield, Missouri, United States

CoxHealth South Hospital, Springfield, Missouri, United States

Nebraska Methodist Hospital, Omaha, Nebraska, United States

Women's Cancer Center of Nevada, Las Vegas, Nevada, United States

Cooper Hospital University Medical Center, Camden, New Jersey, United States

Carolinas Medical Center, Charlotte, North Carolina, United States

Novant Health Presbyterian Medical Center, Charlotte, North Carolina, United States

Summa Akron City Hospital/Cooper Cancer Center, Akron, Ohio, United States

Case Western Reserve University, Cleveland, Ohio, United States

Cleveland Clinic Cancer Center/Fairview Hospital, Cleveland, Ohio, United States

Cleveland Clinic Foundation, Cleveland, Ohio, United States

Riverside Methodist Hospital, Columbus, Ohio, United States

Hillcrest Hospital Cancer Center, Mayfield Heights, Ohio, United States

Lake University Ireland Cancer Center, Mentor, Ohio, United States

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States

Tulsa Cancer Institute, Tulsa, Oklahoma, United States

Abington Memorial Hospital, Abington, Pennsylvania, United States

Geisinger Medical Center, Danville, Pennsylvania, United States

Geisinger Medical Center-Cancer Center Hazleton, Hazleton, Pennsylvania, United States

Geisinger Medical Group, State College, Pennsylvania, United States

Geisinger Wyoming Valley, Wilkes-Barre, Pennsylvania, United States

Women and Infants Hospital, Providence, Rhode Island, United States

Greenville Health System Cancer Institute-Faris, Greenville, South Carolina, United States

Greenville Health System Cancer Institute-Eastside, Greenville, South Carolina, United States

Greenville Health System Cancer Institute-Spartanburg, Spartanburg, South Carolina, United States

Avera Cancer Institute, Sioux Falls, South Dakota, United States

University of Virginia, Charlottesville, Virginia, United States

University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States

D N Greenwald Center, Mukwonago, Wisconsin, United States

Oconomowoc Memorial Hospital-ProHealth Care Inc, Oconomowoc, Wisconsin, United States

Waukesha Memorial Hospital - ProHealth Care, Waukesha, Wisconsin, United States

Contact Details

Name: Linda Duska

Affiliation: NRG Oncology

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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