Ixabepilone in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Previously Treated With Chemotherapy
Recurrent Uterine Corpus Sarcoma, Uterine Corpus Leiomyosarcoma
About this trial
This is an interventional treatment trial for Recurrent Uterine Corpus Sarcoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed uterine leiomyosarcoma Persistent or recurrent disease that is refractory to curative or established treatments Histologic confirmation of the original primary tumor is required Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) Each lesion must be ≥ 10 mm by CT scan, MRI, or caliper measurement by clinical exam OR ≥ 20 mm by chest x-ray Lymph nodes must be ≥ 15 mm in short axis by CT scan or MRI Must have ≥ 1 "target lesion" to assess response Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence ≥ 90 days following completion of radiotherapy Not eligible for a higher priority GOG protocol, if one exists Must have had 1 prior cytotoxic regimen that included a taxane regimen for management of leiomyosarcoma Single-agent or multi-agent therapy allowed Patients who did not receive prior therapy with a taxane (e.g., docetaxel) must receive a second regimen that includes a taxane No known brain metastases GOG performance status 0-2 Life expectancy > 6 months ANC ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Creatinine ≤ 1.5 times upper limit of normal (ULN) Bilirubin ≤ 1.5 times ULN AST ≤ 3 times ULN Alkaline phosphatase ≤ 2.5 times ULN Peripheral neuropathy (sensory or mother) ≤ grade 1 Negative pregnancy test Not pregnant or nursing Fertile patients must use effective contraception prior to and for the duration of study participation Free of active infection requiring antibiotics Uncomplicated urinary tract infection allowed No other invasive malignancy except non-melanoma skin cancer or curatively treated localized cancer of the breast, head and neck, or skin that was completed more than 3 years ago and the patient remains free of recurrence or metastatic disease No history of a severe hypersensitivity reaction to agents containing Cremophor EL or its derivatives (e.g., polyoxyethylated castor oil) No uncontrolled intercurrent illness including, but not limited to, any of the following: Ongoing or active infection Symptomatic congestive heart failure Unstable angina Cardiac arrhythmia Psychiatric illness and/or social situations that would limit compliance with study requirements No concurrent amifostine or other protective agents Recovered from effects of recent surgery, radiotherapy, or chemotherapy At least 1 week since prior hormonal therapy Hormonal therapy (cytotoxic or non-cytotoxic) not counted as prior regimen At least 3 weeks since any other prior therapy directed to the malignant tumor, including immunologic agents At least 4 weeks since prior radiation therapy One prior non-cytotoxic (biologic or cytostatic) regimen, administered as part of the previous cytotoxic regimen or in addition to it, allowed Non-cytotoxic agents include, but are not limited to, the following: Monoclonal antibodies Cytokines Small-molecule inhibitors of signal transduction More than 3 years since radiotherapy for localized cancer of the breast, head and neck, or skin provided patient remains free of recurrence or metastatic disease No prior ixabepilone No prior chemotherapy for any abdominal or pelvic tumor other than for the treatment of uterine leiomyosarcoma within the past 3 years Prior chemotherapy for localized breast cancer allowed provided it was completed more than 3 years ago and patient remains free of recurrent or metastatic disease No other concurrent investigational agents No concurrent strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, amprenavir, indinavir, nelfinavir, delavirdine, voriconazole, or grapefruit juice) or CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifampicin, rifabutin, phenobarbital, or St. John wort) No concurrent combination antiretroviral therapy for HIV-positive patients
Sites / Locations
- Gynecologic Oncology Group of Arizona
- University of Arkansas for Medical Sciences
- Los Angeles County-USC Medical Center
- USC / Norris Comprehensive Cancer Center
- University of Colorado Cancer Center - Anschutz Cancer Pavilion
- Hartford Hospital
- Saint Francis Hospital and Medical Center
- The Hospital of Central Connecticut
- Florida Gynecologic Oncology
- John B Amos Cancer Center
- Saint Alphonsus Cancer Care Center-Boise
- Rush University Medical Center
- University of Chicago Comprehensive Cancer Center
- Sudarshan K Sharma MD Limted-Gynecologic Oncology
- Advocate Christ Medical Center
- Cadence Cancer Center in Warrenville
- Saint Vincent Oncology Center
- University of Iowa Hospitals and Clinics
- Greater Baltimore Medical Center
- Saint Joseph Mercy Hospital
- Michigan Cancer Research Consortium Community Clinical Oncology Program
- Oakwood Hospital and Medical Center
- Henry Ford Hospital
- Saint John Hospital and Medical Center
- Hurley Medical Center
- Genesys Regional Medical Center-West Flint Campus
- Allegiance Health
- Borgess Medical Center
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Sparrow Hospital
- Saint Mary Mercy Hospital
- Saint Joseph Mercy Oakland
- Saint Joseph Mercy Port Huron
- Saint Mary's of Michigan
- Saint John Macomb-Oakland Hospital
- Singing River Hospital
- Phelps County Regional Medical Center
- Saint John's Clinic-Rolla-Cancer and Hematology
- Washington University School of Medicine
- Mercy Hospital Springfield
- Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
- CoxHealth South Hospital
- Nebraska Methodist Hospital
- Women's Cancer Center of Nevada
- Cooper Hospital University Medical Center
- Carolinas Medical Center
- Novant Health Presbyterian Medical Center
- Summa Akron City Hospital/Cooper Cancer Center
- Case Western Reserve University
- Cleveland Clinic Cancer Center/Fairview Hospital
- Cleveland Clinic Foundation
- Riverside Methodist Hospital
- Hillcrest Hospital Cancer Center
- Lake University Ireland Cancer Center
- University of Oklahoma Health Sciences Center
- Tulsa Cancer Institute
- Abington Memorial Hospital
- Geisinger Medical Center
- Geisinger Medical Center-Cancer Center Hazleton
- Geisinger Medical Group
- Geisinger Wyoming Valley
- Women and Infants Hospital
- Greenville Health System Cancer Institute-Faris
- Greenville Health System Cancer Institute-Eastside
- Greenville Health System Cancer Institute-Spartanburg
- Avera Cancer Institute
- University of Virginia
- University of Wisconsin Hospital and Clinics
- D N Greenwald Center
- Oconomowoc Memorial Hospital-ProHealth Care Inc
- Waukesha Memorial Hospital - ProHealth Care
Arms of the Study
Arm 1
Experimental
Treatment (ixabepilone)
Patients receive ixabepilone IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.