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Brief Title: Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer
Official Title: A Phase II Evaluation of Ixabepilone (NSC #710428) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus
Study ID: NCT01168232
Brief Summary: This phase II trial is studying the side effects and how well ixabepilone works in treating patients with persistent or recurrent uterine cancer. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells of by stopping them from dividing.
Detailed Description: PRIMARY OBJECTIVES: I. To determine the response rate of ixabepilone in patients with persistent or recurrent carcinosarcoma of the uterus. II. To determine the nature and degree of toxicity of ixabepilone in this cohort of patients. SECONDARY OBJECTIVES: I. To determine the duration of progression-free survival and overall survival. TERTIARY OBJECTIVES: I. To examine the expression of class III beta-tubulin in carcinosarcoma of the uterus. II. To explore the association between class III beta-tubulin expression in carcinosarcoma of the uterus and response, progression-free and overall survival. OUTLINE: Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats 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
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
John Muir Medical Center-Concord Campus, Concord, California, United States
John Muir Medical Center-Walnut Creek, Walnut Creek, California, United States
University of Colorado Hospital, Aurora, Colorado, United States
Hartford Hospital, Hartford, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint Francis, Hartford, Connecticut, United States
The Hospital of Central Connecticut, New Britain, Connecticut, United States
Florida Hospital Orlando, Orlando, Florida, United States
Memorial University Medical Center, Savannah, 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
Good Samaritan Regional Health Center, Mount Vernon, Illinois, United States
Northwestern Medicine Cancer Center Warrenville, Warrenville, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
Saint Vincent Hospital and Health Care Center, Indianapolis, Indiana, United States
Medical Oncology and Hematology Associates-West Des Moines, Clive, Iowa, United States
Mercy Cancer Center-West Lakes, Clive, Iowa, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Iowa-Wide Oncology Research Coalition NCORP, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Laurel, Des Moines, Iowa, United States
Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
Iowa Lutheran Hospital, Des Moines, Iowa, United States
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
Methodist West Hospital, West Des Moines, Iowa, United States
Mercy Medical Center-West Lakes, West Des Moines, Iowa, United States
Sinai Hospital of Baltimore, Baltimore, Maryland, United States
Michigan Cancer Research Consortium NCORP, Ann Arbor, Michigan, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Beaumont Hospital-Dearborn, Dearborn, Michigan, United States
Saint John Hospital and Medical Center, Detroit, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Genesys Regional Medical Center-West Flint Campus, Flint, Michigan, United States
Genesys Regional Medical Center, Grand Blanc, 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
Lake Huron Medical Center, Port Huron, Michigan, United States
Saint Mary's of Michigan, Saginaw, Michigan, United States
Saint John Macomb-Oakland Hospital, Warren, Michigan, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Mercy Hospital Joplin, Joplin, Missouri, United States
Mercy Clinic-Rolla-Cancer and Hematology, Rolla, Missouri, United States
Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Cancer Research for the Ozarks NCORP, Springfield, Missouri, United States
Mercy Hospital 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
State University of New York Downstate Medical Center, Brooklyn, New York, United States
Stony Brook University Medical Center, Stony Brook, New York, United States
Carolinas Medical Center/Levine Cancer Institute, Charlotte, North Carolina, United States
Duke University Medical Center, Durham, 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
Oklahoma Cancer Specialists and Research Institute-Tulsa, Tulsa, Oklahoma, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Women and Infants Hospital, Providence, Rhode Island, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Name: Carolyn McCourt
Affiliation: NRG Oncology
Role: PRINCIPAL_INVESTIGATOR