drugset / Trial / NCT00352079

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

NCT00352079

Phase 3 Terminated 41 enrolled NCIC Clinical Trials Group
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2007-01-04
Primary completion
2012-01-06
Completion
2012-01-06

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gefitinib Small molecule 250 mg Oral
Comparator BCG vaccine Vaccine Intrathecal