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 range
18 Years – 120 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.