drugset / Trial / NCT00352079
BCG With or Without Gefitinib in Treating Patients With High-Risk Bladder Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Gefitinib | Small molecule | 250 mg | Oral |
| Comparator | BCG vaccine | Vaccine | — | Intrathecal |