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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
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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
Name: Linda Duska
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR