A Phase II Evaluation of Ixabepilone (IND #59699, NSC #710428) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus
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: This is a multicenter study.
Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the
absence of disease progression or unacceptable toxicity. Tumor tissue samples from prior
surgery may be collected for beta-III tubulin expression analysis by IHC.
After completion of study therapy, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Frequency and duration of objective response (complete or partial response) as measured by RECIST
Up to 5 years
No
Linda Duska
Principal Investigator
Gynecologic Oncology Group
United States: Food and Drug Administration
NCI-2011-02656
NCT01220609
November 2010
Name | Location |
---|---|
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Hurley Medical Center | Flint, Michigan 48503 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Waukesha Memorial Hospital | Waukesha, Wisconsin 53188 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
Hartford Hospital | Hartford, Connecticut 06102-5037 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
Advocate Christ Medical Center | Oak Lawn, Illinois 60453 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
Singing River Hospital | Pascagoula, Mississippi 39581 |
Greater Baltimore Medical Center | Baltimore, Maryland 21204 |
Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Phelps County Regional Medical Center | Rolla, Missouri 65401 |
University of Virginia | Charlottesville, Virginia 22908 |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Florida Gynecologic Oncology | Fort Myers, Florida 33901 |
Hillcrest Hospital Cancer Center | Mayfield Heights, Ohio 44124 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
University of Southern California | Los Angeles, California 90033 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
The Hospital of Central Connecticut | New Britain, Connecticut 06050 |
John B Amos Cancer Center | Columbus, Georgia 31904 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield | Springfield, Missouri 65802 |
Saint John's Hospital | Springfield, Missouri 65804 |
Cox Medical Center | Springfield, Missouri 65807 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
Geisinger Wyoming Valley | Wilkes-Barre, Pennsylvania 18711 |
Greenville CCOP | Greenville, South Carolina 29615 |
Oconomowoc Memorial Hospital-ProHealth Care Inc | Oconomowoc, Wisconsin 53066-3896 |
Cancer Care Associates-Yale | Tulsa, Oklahoma 74136-1929 |
Women and Infants Hospital | Providence, Rhode Island 02905 |
Lake University Ireland Cancer Center | Mentor, Ohio 44060 |
University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora, Colorado 80045 |
Cancer Centers of the Carolinas - Faris | Greenville, South Carolina 29605 |
Women's Cancer Center of Nevada | Las Vegas, Nevada 89109 |
Central DuPage Hospital Cancer Center | Warrenville, Illinois 60555 |
Saint John's Clinic-Rolla-Cancer and Hematology | Rolla, Missouri 65401 |
Los Angeles County-USC Medical Center | Los Angeles, California 90033 |
Gynecologic Oncology Group of Arizona | Phoenix, Arizona 85012 |
Sudarshan K Sharma MD Limted-Gynecologic Oncology | Hinsdale, Illinois 60521 |
Saint Vincent Oncology Center | Indianapolis, Indiana 46260 |
Summa Akron City Hospital | Akron, Ohio 44304 |
Geisinger Medical Center-Cancer Center Hazelton | Hazleton, Pennsylvania 18201 |
Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland, Ohio 44111 |
D N Greenwald Center | Mukwonago, Wisconsin 53149 |