OBJECTIVES:

• Determine the 6-month progression-free survival of patients with persistent or recurrent endometrial carcinoma after receiving gefitinib.
• Determine the nature and degree of toxicity of this drug in these patients.
• Determine the progression-free and overall survival of patients treated with this drug.
• Determine the effects of this drug on the levels of epidermal growth factor receptors (EGFR), c-ErbB2 (HER-2/neu) receptors, estrogen receptors (ER), and progesterone receptors (PR) (both PR and PRB) in tumor specimens of these patients.
• Determine if an association exists between the levels of EGFR, ER, PR, PRB, and HER-2/neu serum concentrations of gefitinib, gefitinib activity, and soluble EGFR and clinical outcome in patients treated with this drug.
• Determine the frequency of clinical response (partial and complete response) in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days 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: A total of 22-60 patients will be accrued for this study within 2.5-6 years.

DISEASE CHARACTERISTICS:

• Histologically confirmed primary endometrial carcinoma

  • Recurrent or persistent disease

• Received 1 prior chemotherapy regimen for endometrial carcinoma

  • Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or nonsurgical assessment

• At least 1 unidimensionally measurable lesion

  • At least 20 mm by conventional techniques (including palpation, plain x-ray, CT scan, and MRI) OR
  • At least 10 mm by spiral CT scan
  • Must have at least 1 target lesion for response assessment

  • Tumors within a previously irradiated field are designated as non-target lesions

    • Disease in a previously irradiated field as the only site of measurable disease is allowed only if there has been clear progression of the lesion since the completion of radiotherapy
• Must have a tumor that is accessible for guided core needle or fine needle biopsy
• Ineligible for a higher priority GOG protocol, defined as any active phase III protocol for the same patient population, if one exists

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• GOG 0-2 (for patients who received 1 prior regimen)
• GOG 0-1 (for patients who received 2 prior regimens)

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT no greater than 2.5 times ULN
• Alkaline phosphatase no greater than 2.5 times ULN

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No unstable cardiac disease or myocardial infarction within the past 6 months
• History of coronary artery disease, congestive heart failure, or dysrhythmia allowed if on a stable regimen for at least 3 months

Other:

• No active infection requiring antibiotics
• No active corneal disease (e.g., keratoconjunctivitis)
• No grade 2 or greater sensory and motor neuropathy
• No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
• No signs or symptoms of bowel dysfunction that would preclude successful ingestion of oral study medication
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 3 weeks since prior immunologic agents directed at malignant tumor
• No concurrent anticancer immunotherapy

Chemotherapy:

• See Disease Characteristics
• At least 3 weeks since prior chemotherapy directed at the malignant tumor and recovered
• No prior non-cytotoxic chemotherapy for recurrent or persistent disease
• No concurrent anticancer chemotherapy

Endocrine therapy:

• At least 1 week since prior hormonal therapy directed at malignant tumor
• No concurrent anticancer hormonal therapy

Radiotherapy:

• See Disease Characteristics
• At least 3 weeks since prior radiotherapy directed at malignant tumor and recovered
• No concurrent anticancer radiotherapy

Surgery:

• At least 4 weeks since prior surgery except minor procedures using local anesthesia (e.g., placement of a central venous port) and recovered

Other:

• At least 3 weeks since any other prior therapy directed at malignant tumor
• One additional prior cytotoxic regimen for recurrent or persistent disease allowed
• No prior gefitinib or other epidermal growth factor receptor inhibitor
• No prior cancer treatment that would contraindicate study therapy
• No concurrent CYP 3A4 inducers (including phenytoin, carbamazepine, barbiturates, nafcillin, rifampin, or Hypericum perforatum [St. John's Wort])
• No other concurrent investigational or antineoplastic agents
• No concurrent chlorpromazine