BCG With or Without Gefitinib in Treating Patients With High-Risk Bladder Cancer

DISEASE CHARACTERISTICS: Histologically confirmed transitional cell carcinoma (TCC) of the bladder meeting ≥ 1 of the following criteria: Noninvasive papillary carcinoma (Ta) with ≥ 1 of the following characteristics: Recurrence of bladder tumor(s) ≥ grade 2 within 6 months after transurethral resection (TUR) Three or more bladder tumors ≥ grade 2 at the time of TUR Bladder tumor(s) ≥ 5 cm in size and ≥ grade 2 at the time of TUR Any grade 3 bladder tumor(s) Carcinoma in situ (Tis) At least grade 2 tumor that invades the subepithelial connective tissue (T1) Has undergone TUR of all visible bladder lesions within the past 21 to 60 days with biopsy of the underlying bladder wall for all tumors and cold-cup biopsy of all suspicious areas No metastatic disease as confirmed by negative radiology within the past 16 weeks, including the following: Chest x-ray Imaging of the upper urinary tract by 1 of the following methods: CT scan, MRI, or ultrasound of the abdomen and pelvis Intravenous pyelogram Retrograde pyelogram No evidence of TCC of the upper urinary tract No mixed histology of bladder cancer (i.e., TCC and squamous cell carcinoma of the bladder or TCC and small cell carcinoma of the bladder) at the most recent TUR PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy > 5 years Negative routine urine microscopy and negative urine culture within the past 14 days Willing to complete quality of life questionnaires in English or French Inability to complete questionnaires due to illiteracy in English or French, loss of sight, or other reason allowed WBC ≥ 3,000/mm³ Absolute neutrophil count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST and ALT ≤ 1.5 times ULN Alkaline phosphatase ≤ 1.5 times ULN Creatinine ≤ 1.5 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study completion No significant history of cardiac disease including, but not limited to, any of the following: Uncontrolled high blood pressure Unstable angina Congestive heart failure Myocardial infarction within the past year Cardiac ventricular arrhythmias requiring medication No active urinary tract infection No active infection, including tuberculosis No serious underlying medical conditions that would impair the ability of the patient to receive protocol treatment No febrile illness or gross hematuria No impaired immune response from any cause (congenital, therapy, or disease) No clinically significant or untreated ophthalmologic condition (e.g., Sjögren's syndrome) No gastrointestinal conditions (e.g., Crohn's disease or ulcerative colitis) No history of psychiatric or neurological disorder that would limit study compliance No other malignancies except for adequately treated nonmelanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥ 5 years No contraindications to spinal or general anesthesia as required for a TUR No known hypersensitivity to BCG or gefitinib No history of allergic reactions attributed to compounds of similar chemical or biologic composition to the study drugs PRIOR CONCURRENT THERAPY: See Disease Characteristics More than 12 months since prior intravesical immunotherapy (including BCG +/- interferon) More than 6 months since prior intravesical chemotherapy (including mitomycin C, thiotepa, doxorubicin hydrochloride) Single dose of intravesical mitomycin C at the time of the most recent TUR (within the past 21 to 60 days) allowed if considered standard care No other prior or concurrent immune modulator therapy No prior pelvic radiation No prior gefitinib No other concurrent experimental anticancer drugs No concurrent use of drugs that induce CYP3A4 enzymes that have been shown to significantly reduce plasma concentrations of gefitinib (including phenytoin, carbamazepine, barbiturates, rifampin, or Hypericum perforatum [St. John's wort]) No concurrent grapefruit juice