Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352079
Status:
TERMINATED
Last Update Posted:
2023-08-04
First Post:
2006-07-13
Brief Title:
BCG With or Without Gefitinib in Treating Patients With High-Risk Bladder Cancer
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
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
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
terminated due to poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CAN-NCIC-BL11 | OTHER | None | None |
| CDR0000486873 | OTHER | PDQ | None |