Ixabepilone in Treating Patients With Recurrent or Persistent Uterine Cancer

Inclusion Criteria:

• Histologically confirmed uterine carcinosarcoma

  • Persistent or recurrent disease refractory to curative or established treatments
  • Malignant mixed müllerian tumor
  • Homologous or heterologous type
• Progressive disease after local therapy

• 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

• Patient 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 after completion of radiotherapy

• Patient must have had 1 prior chemotherapeutic regimen for management of carcinosarcoma that may have included chemotherapy, chemotherapy and radiotherapy, and/or consolidation/maintenance therapy

  • Chemotherapy administered in conjunction with primary radiation as a radio-sensitizer is counted as a systemic chemotherapy regimen
  • Patients who have not received a prior taxane therapy (e.g., paclitaxel or docetaxel) must receive a second regimen that includes a taxane
• Patients must not be eligible for a higher priority GOG or Rare Tumor protocol, if one exists
• ECOG performance status 0-2
• ANC ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Creatinine ≤ 1.5 times upper limit of normal (ULN)
• Bilirubin ≤ 1.5 times ULN
• AST and ALT ≤ 3.0 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• Peripheral neuropathy (sensory and motor) ≤ grade 1
• No active infection requiring antibiotics except uncomplicated urinary tract infection
• No history of severe grade 3-4 hypersensitivity reaction to agents containing Cremophor® EL or its derivatives (e.g., polyoxyethylated castor oil)
• More than 3 years since other invasive malignancy except non-melanoma skin cancer
• No concurrent amifostine or other protective reagents
• Recovered from recent surgery, radiotherapy, or chemotherapy
• At least 1 week since prior hormonal therapy
• At least 3 weeks since any prior therapy directed at the malignant tumor, including biological and immunological agents

• One prior non-cytotoxic (biologic or cytostatic) regimen for management of recurrent or persistent disease that includes, but is not limited to, any of the following allowed:

  • Monoclonal antibodies
  • Cytokines
  • Small-molecule inhibitors of signal transduction

• More than 3 years since prior radiotherapy to any portion of the abdominal cavity or pelvis other than for uterine carcinosarcoma

  • Prior radiation for localized cancer of the breast, head and neck, or skin allowed provided the patient remains free of recurrent or metastatic disease

• No prior chemotherapy for any abdominal or pelvic tumor, other than for uterine carcinosarcoma, within the past 3 years

  • More than 3 years since prior adjuvant chemotherapy for localized breast cancer allowed provided patient has remained free of recurrent or metastatic disease
• No prior ixabepilone
• No prior cancer therapy that contraindicates study treatment