A Phase II Evaluation of Ixabepilone (IND #59699, NSC #710428) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus
PRIMARY OBJECTIVES:
I. To determine the response rate of patients with persistent or recurrent carcinosarcoma of
the uterus treated with ixabepilone.
II. To determine the nature and degree of toxicity of this regimen in these patients.
SECONDARY OBJECTIVES:
I. To determine the duration of progression-free survival and overall survival of patients
treated with this regimen.
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 with response,
progression-free survival, and overall survival in these patients.
OUTLINE: This is a multicenter study.
Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in
the absence of disease progression or unacceptable toxicity.
Tumor tissue samples from prior surgery may be collected for class III beta-tubulin 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: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Frequency of patients with objective tumor response
Up to 5 years
No
Carolyn McCourt
Principal Investigator
Gynecologic Oncology Group
United States: Food and Drug Administration
NCI-2011-02056
NCT01168232
September 2010
Name | Location |
---|---|
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Hurley Medical Center | Flint, Michigan 48503 |
Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
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 |
John Muir Medical Center | Walnut Creek, California 94598 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Genesys Regional Medical Center | Grand Blanc, Michigan 48439-8066 |
Duke University Medical Center | Durham, North Carolina 27710 |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Indiana University Medical Center | Indianapolis, Indiana 46202 |
Virginia Commonwealth University | Richmond, Virginia |
Florida Hospital | Orlando, Florida 32803 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
Hillcrest Hospital Cancer Center | Mayfield Heights, Ohio 44124 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
The Hospital of Central Connecticut | New Britain, Connecticut 06050 |
Medical Oncology and Hematology Associates-West Des Moines | Clive, Iowa 50325 |
Iowa Oncology Research Association CCOP | Des Moines, Iowa 50309 |
Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates-Des Moines | Des Moines, Iowa 50309 |
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 |
Cancer Care Associates-Yale | Tulsa, Oklahoma 74136-1929 |
Women and Infants Hospital | Providence, Rhode Island 02905 |
Lake University Ireland Cancer Center | Mentor, Ohio 44060 |
Stony Brook University Medical Center | Stony Brook, New York 11794 |
John Muir Medical Center-Concord Campus | Concord, California 94520 |
University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora, Colorado 80045 |
State University of New York Downstate Medical Center | Brooklyn, New York 11203 |
Women's Cancer Center of Nevada | Las Vegas, Nevada 89109 |
Sudarshan K Sharma MD Limted-Gynecologic Oncology | Hinsdale, Illinois 60521 |
Saint Vincent Oncology Center | Indianapolis, Indiana 46260 |
Methodist West Hospital | West Des Moines, Iowa 50266-7700 |
Summa Akron City Hospital | Akron, Ohio 44304 |
Genesys Regional Medical Center-West Flint Campus | Flint, Michigan 48532 |
Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland, Ohio 44111 |
Mercy Cancer Center-West Lakes | Clive, Iowa 50325 |
Mercy Medical Center-West Lakes | West Des Moines, Iowa 50266 |