Ixabepilone in Treating Patients With Recurrent or Persistent Leiomyosarcoma of the Uterus Previously Treated With Chemotherapy

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