A Phase II Evaluation of Ixabepilone (IND #59699, NSC #710428) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus

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