NCT00352079

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: Primary * Compare the impact of gefitinib and intravesical BCG vs intravesical BCG alone on time to treatment failure in patients with high-risk, superficial transitional cell carcinoma of the bladder. Secondary * Compare the complete response rates in patients with carcinoma in situ receiving gefitinib and intravesical BCG vs patients receiving intravesical BCG alone. * Compare the time to recurrence in patients treated with these regimens. * Compare the time to progression in patients treated with these regimens. * Compare the overall survival of patients treated with these regimens. * Characterize and contrast the adverse event and safety profile of these regimens in these patients. * Compare the effects of these regimens on quality of life in these patients. OUTLINE: This is a randomized, prospective, open-label, controlled, multicenter study. Patients are stratified according to study center, status of tumor (primary vs recurrent), carcinoma in situ (yes vs no), prior BCG therapy (yes vs no), and single dose of intravesical mitomycin C at the time of the most recent transurethral resection (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive induction therapy comprising intravesical BCG once weekly for 6 weeks. Patients then receive maintenance therapy comprising intravesical BCG once weekly for 3 weeks. * Arm II: Patients receive induction therapy comprising intravesical BCG once weekly for 6 weeks and oral gefitinib once daily for 12 weeks. Patients then receive maintenance therapy comprising intravesical BCG once weekly for 3 weeks and oral gefitinib once daily for 12 weeks. In both arms, treatment with maintenance therapy repeats at 3, 6, 12, 18, 24, 30, and 36 months for a total of 7 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, periodically during study therapy, and then at 3 and 6 months after completion of study therapy. After study completion, patients are followed every 3 months for 2 years, every 6 months for 4 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 166 patients will be accrued for this study.

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-01-04
• Primary completion: 2012-01-06
• Completion: 2012-01-06
• First posted: 2006-07-14
• Last updated: 2023-08-04

Locations

6 sites across 1 country: Canada