Please assess the completion status of the following clinical trial:

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

Study Design Characteristics:
- Allocation: RANDOMIZED
- Intervention Model: PARALLEL
- Observational Model: None
- Primary Purpose: TREATMENT
- Time Perspective: None
- Masking: NONE
- Phase: PHASE3
- Number of Arms: 2.0

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

- Gender: ALL
- Minimum Age: 18 Years
- Maximum Age: 120 Years
- Healthy Volunteers: f

Study Arms:
- Intravesicle BCG (Type: ACTIVE_COMPARATOR): Induction:~q weekly x 6 (cycle 1)~Maintenance:~q weekly x 3 at 3, 6, 12, 18, 24, 30, 36 months postrandomization (cycles 2 - 8)
- Iressa and Intravesicle BCG (Type: ACTIVE_COMPARATOR): Intravesical BCG:~Induction:~q weekly x 6 (cycle 1)~Maintenance:~q weekly x 3 at 3, 6, 12, 18, 24, 30, 36 months post- 2 randomization (cycles 2 - 8)~Iressa® 250 mg PO Daily for 12 weeks starting on day 1 of each cycle of intravesical BCG therapy (cycles 1 - 8)

Based on this trial design, predict the completion outcome and termination type (if applicable).