• Clinical response by RECIST criteria every 8 weeks [ Designated as safety issue: No ]
  
• Clinical response and intensity of estrogen receptor expression by RECIST criteria 8 weeks after treatment [ Designated as safety issue: No ]
  

• Toxicity of fulvestrant by Common Toxicity Criteria at 4 weeks [ Designated as safety issue: Yes ]
  
• Disease-free and overall survival at 4 weeks [ Designated as safety issue: No ]
  

OBJECTIVES:

• Compare the probability of clinical response in estrogen receptor (ER)-positive vs ER-negative patients recurrent, persistent, or metastatic endometrial cancer treated with fulvestrant.
• Compare the relationship between response rate and intensity of receptor expression in patients treated with this drug.
• Determine the frequency and intensity of toxicity of this drug in these patients.

OUTLINE: Patients receive fulvestrant intramuscularly on day 1. Treatment repeats every 28 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: Approximately 22-60 patients will be accrued for this study within 8-19 months.

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