Phase II Study of Faslodex In Recurrent/Metastatic Endometrial Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed recurrent, persistent, or metastatic endometrial cancer that
is not curable with surgery or radiotherapy

- Estrogen receptor (ER) and progesterone receptor status known by immunohistochemistry

- ER positive or negative allowed

- Measurable disease

- At least 1 target lesion not within a previously irradiated field OR irradiated
target lesion with clear disease progression

- At least 20 mm by conventional techniques, including palpation, x-ray, CT scan,
MRI, OR at least 10 mm by spiral CT scan

PATIENT CHARACTERISTICS:

Age:

- Not specified

Performance status:

- GOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥100,000/mm^3

- No prior bleeding diathesis (disseminated intravascular coagulation, clotting factor
deficiency, or requirement for anticoagulants)

Hepatic:

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- SGOT ≤ 3 times ULN

- Alkaline phosphatase ≤ 3 times ULN

Renal:

- Creatinine ≤ 2 mg/dL

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No hypersensitivity to castor oil

- No other concurrent malignancy except nonmelanoma skin cancer

- No other prior malignancy within past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy for persistent, recurrent, or metastatic endometrial cancer

- No more than 1 prior chemotherapy regimen for newly diagnosed endometrial cancer that
has subsequently recurred

Endocrine therapy:

- At least 3 weeks since prior hormonal therapy and recovered

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

Surgery:

- See Disease Characteristics

- At least 3 weeks since prior surgery and recovered