NCT00352079 - BCG With or Without Gefitinib in Treating Patients With High-Risk Bladder Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 4, 2007

Primary Completion Date

January 6, 2012

Study Completion Date

January 6, 2012

Conditions

Bladder Cancer

Interventions

BIOLOGICAL

BCG vaccine

"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)"

DRUG

gefitinib

Iressa® 250 mg PO Daily for 12 weeks starting on day 1 of each cycle of intravesical BCG therapy (cycles 1 - 8)

PROCEDURE

quality-of-life assessment

Each cycle and at 3 and 6 months after treatment discontinuation

Trial Locations (6)

V5Z 1M9

Clinical Research Unit at Vancouver Coastal, Vancouver

L8N 4A6

Hamilton and District Urology Association, Hamilton

N6A 4L6

London Regional Cancer Program, London

M5G 2M9

Univ. Health Network-Princess Margaret Hospital, Toronto

G1R 2J6

CHUQ-Pavillon Hotel-Dieu de Quebec, Québec

J1H 5N4

Centre hospitalier universitaire de Sherbrooke, Sherbrooke