BCG With or Without Gefitinib in Treating Patients With High-Risk Bladder Cancer (NCT00352079) | Clinical Trial Compass
TerminatedPhase 3
BCG With or Without Gefitinib in Treating Patients With High-Risk Bladder Cancer
Stopped: terminated due to poor accrual
Canada41 participantsStarted 2007-01-04
Plain-language summary
RATIONALE: Biological therapies, such as BCG, may stimulate the immune system in different ways and stop tumor cells from growing. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving BCG together with gefitinib may kill more tumor cells. It is not yet known whether BCG is more effective with or without gefitinib in treating bladder cancer.
PURPOSE: This randomized phase III trial is studying BCG and gefitinib to see how well they work compared to BCG alone in treating patients with high-risk bladder cancer.
Who can participate
Age range18 Years – 120 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 c…