A Study of Ixabepilone as Second-line Therapy for Locally Advanced, Recurrent, or Metastatic Endometrial Cancer

Key Inclusion Criteria

* Women aged 18 years and older
* Histologic or cytologic diagnosis of endometrial carcinoma
* Evidence that the cancer is advanced, recurrent, or metastatic and not curable by local measures, such as surgery or radiation.
* Karnofsky performance status \>=70
* Measurable or nonmeasurable disease that has progressed since last treatment.

  * If only disease is confined to a solitary lesion, its neoplastic nature must be confirmed by histology or cytology.
  * Disease in a previously irradiated field is acceptable as the only site of measurable disease only if there has been clear progression since completion of radiotherapy.
* All therapy directed at endometrial cancer must be discontinued 21 days prior to start of treatment, except for hormonal therapy which must be discontinued at least 1 week prior to start of study treatment. Concurrent administration of hormone replacement therapy is allowed.
* Prior therapy: Participants must have failed 1 prior platinum-based chemotherapeutic regimen for endometrial cancer. May have received 2 prior chemotherapy regimens if 1 regimen was given for stage I or II disease. May have received any number of prior non-cytotoxic regimens such as monoclonal antibodies, cytokines, signal transduction inhibitors, or hormonal therapy. Previous radiation therapy is allowed.

Key Exclusion Criteria

* Carcinosarcoma (malignant mixed mullerian tumor)
* Endometrial leiomyosarcoma and endometrial stromal sarcomas
* Participants who received no prior chemotherapy for endometrial cancer or ≥2 prior chemotherapy regimens (exceptions defined in protocol)
* Known brain metastases
* Receipt of prior ixabepilone therapy
* Concurrent active infection requiring antibiotics or other therapy
* Concurrent unstable disease or other debilitating illness, such as congestive heart failure, unstable angina, myocardial infarction, or other cardiac disease that could jeopardize participation, within the last 6 months
* For participants whose prior therapy did not include an anthracycline and therefore may be randomized to doxorubicin, left ventricular ejection fraction \<50% as measured by multigated radionuclide angiography or echocardiography
* History of malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix, or carcinoma in situ of the breast, within the last 5 years that has not been treated with chemotherapy
* Known human immunodeficiency viral infection
* Psychiatric disorders or other conditions rendering the participant incapable of complying with protocol requirements
* Absolute neutrophil count \<1500/mm\^3
* Platelets \<100,000/mm\^3
* Hemoglobin \<9 g/dL
* Total bilirubin \>1.5\*upper limit of normal (ULN), except for those with Gilbert's disease
* Aspartate aminotransferase or alanine aminotransferase \>2.5\*ULN
* Serum creatinine \>1.5\*ULN
* Grade ≥2 neuropathy (sensory or motor)
* No concurrent therapy (chemotherapy, hormonal, or investigational) directed at endometrial cancer during the study