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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase III Randomized Study of BCG With Versus Without Gefitinib in Patients With High-Risk Superficial Transitional Cell Carcinoma of the Bladder

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Active 18 and over Other CAN-NCIC-BL11 NCT00352079, BL11

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Has undergone surgery to remove the tumor and biopsy within the past 3-9 weeks
• No metastatic cancer
• No transitional cell carcinoma of the upper urinary tract
• More than 1 year since BCG, interferon, or other biological therapy given into the bladder
• More than 6 months since thiotepa, doxorubicin, or other chemotherapy given into the bladder, except mitomycin
• No previous radiation therapy to the pelvis
• No previous gefitinib
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive BCG into the bladder once a week for 6 weeks. They will then receive BCG into the bladder once a week for 3 weeks as maintenance therapy. Treatment with maintenance therapy may repeat at 3 and 6 months and then every 6 months for up seven courses.

Patients in group two will receive BCG into the bladder once a week for 6 weeks. They will also receive gefitinib by mouth once a day for 12 weeks. Patients will then receive BCG into the bladder once a week for three weeks and gefitinib by mouth once a day for 12 weeks as maintenance therapy. Treatment with maintenance therapy may repeat at 3 and 6 months and then every 6 months for up to seven courses.

Quality of life will be assessed periodically. After finishing treatment, patients will be evaluated every 3 months for 2 years, every 6 months for 4 years, and once a year thereafter.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

NCIC-Clinical Trials Group

Louis Lacombe, MD, Protocol chair		Ph: 418-691-5561 Email: louis.lacombe@crhdq.ulaval.ca

Canada
British Columbia
	Vancouver
	University of British Columbia
		Alan I. So	Ph:  604-875-4111
Ontario
	Hamilton
	McMaster Institute of Urology at St. Joseph Healthcare
		Anil Kapoor	Ph:  905-522-6536
	London
	London Regional Cancer Program at London Health Sciences Centre
		Jonathan Izawa	Ph:  519-685-8550
	Toronto
	Princess Margaret Hospital
		Michael A.S. Jewett	Ph:  416-946-2909
Quebec
	Quebec City
	Centre Hospitalier Universitaire de Quebec
		Louis Lacombe	Ph:  418-691-5O50
	Sherbrooke
	CHUS-Hopital Fleurimont
		Michel Carmel	Ph:  819-346-1110

Registry Information
Official Title		A Phase III Study of IRESSA® in Combination with Intravesical BCG Versus Intravesical BCG Alone in High Risk Superficial Transitional Cell Carcinoma of the Bladder
Trial Start Date		2006-04-12
Trial Completion Date		2012-04-12 (estimated)
Registered in ClinicalTrials.gov		NCT00352079
Date Submitted to PDQ		2006-05-19
Information Last Verified		2008-02-26