Clinical trial NCT00352079 (phase 3, status: terminated)
Conditions: bladder cancer
ICD codes: D30.3, C67.5, C67.9, C79.11, C67.0, C67.1, D41.4
Drugs: gefitinib
SMILES: COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1
Reason stopped: 
    terminated due to poor accrual
  
Eligibility criteria:

        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