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