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
- 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.
- 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
- 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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to treatment failure
Louis Lacombe, MD
Centre Hospitalier Universitaire de Quebec
Canada: Health Canada