Clinical trial NCT00027690 (phase 2, status: completed)
Conditions: recurrent uterine corpus carcinoma
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: gefitinib
SMILES: COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1
Eligibility criteria:

        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