Gefitinib in Treating Patients With Persistent or Recurrent Endometrial Cancer

Inclusion Criteria:

• 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)
  • 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
• Performance status - GOG 0-2 (for patients who received 1 prior regimen)
• Performance status - GOG 0-1 (for patients who received 2 prior regimens)
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• 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
• Creatinine no greater than 1.5 times ULN
• 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
• 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
• At least 3 weeks since prior immunologic agents directed at malignant tumor
• No concurrent anticancer immunotherapy
• 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
• At least 1 week since prior hormonal therapy directed at malignant tumor
• No concurrent anticancer hormonal therapy
• See Disease Characteristics
• At least 3 weeks since prior radiotherapy directed at malignant tumor and recovered
• No concurrent anticancer radiotherapy
• At least 4 weeks since prior surgery except minor procedures using local anesthesia (e.g., placement of a central venous port) and recovered
• 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