A Phase III, Open Label, Randomized, 2 Arm Study of Ixabepilone Administered Every 21 Days Versus Paclitaxel or Doxorubicin Administered Every 21 Days in Women With Advanced Endometrial Cancer Who Have Previously Been Treated With Chemotherapy

Inclusion Criteria:

- Histologically confirmed endometrial cancer, locally advanced, recurrent or
metastatic

- Karnofsky performance status (KPS) ≥ 70

- Measurable or non-measurable disease that has progressed since last treatment

- Receipt of prior platinum based chemotherapy regimen for advanced endometrial cancer

- Subjects may have received 2 prior chemotherapy (ie. cytotoxic) regimens if 1 regimen
was given for Stage I or II disease

- Women, ages 18 to older

Exclusion Criteria:

- Carcinosarcoma (malignant mixed mullerian tumor), endometrial leiomyosarcoma and
endometrial stromal sarcomas

- No prior first-line chemotherapy or receipt of ≥ 2 prior chemotherapy regimens except
as defined in the Inclusion Criteria

- Known brain metastases

- Prior ixabepilone therapy

- Concurrent active infection requiring antibiotics or other therapy

- Concurrent unstable disease or illness that could jeopardize participation in study

- Impaired cardiac function with LVEF of < 50% as measured by MUGA or ECHO

- Malignancy within last 5 years except non-melanoma skin cancer, carcinoma in situ of
the cervix, or of the breast not treated with chemotherapy

- Grade ≥ 2 neuropathy (sensory or motor)

- Inadequate hematologic, renal and hepatic function