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

Phase 3

Terminated

• Conditions: Bladder Cancer
• Interventions: Biological: BCG vaccine; Procedure: quality-of-life assessment; Drug: gefitinib

• Registration Number: NCT00352079
• Lead Sponsor: NCIC Clinical Trials Group

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.

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.

Study Timeline

• Study First Submitted: 2006-07-13
• Study First Submitted QC: 2006-07-13
• Study First Posted: 2006-07-14
• Study Start: 2007-01-04
• Primary Completion: 2012-01-06
• Study Completion: 2012-01-06
• Status Verified: 2020-04
• Last Update Submitted: 2023-08-03
• Last Update Posted: 2023-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravesicle BCG	BCG vaccine	Induction: q weekly x 6 (cycle 1) Maintenance: q weekly x 3 at 3, 6, 12, 18, 24, 30, 36 months postrandomization (cycles 2 - 8)
Intravesicle BCG	quality-of-life assessment	Induction: q weekly x 6 (cycle 1) Maintenance: q weekly x 3 at 3, 6, 12, 18, 24, 30, 36 months postrandomization (cycles 2 - 8)
Iressa and Intravesicle BCG	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) Iressa® 250 mg PO Daily for 12 weeks starting on day 1 of each cycle of intravesical BCG therapy (cycles 1 - 8)
Iressa and Intravesicle BCG	gefitinib	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) Iressa® 250 mg PO Daily for 12 weeks starting on day 1 of each cycle of intravesical BCG therapy (cycles 1 - 8)
Iressa and Intravesicle BCG	quality-of-life assessment	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) Iressa® 250 mg PO Daily for 12 weeks starting on day 1 of each cycle of intravesical BCG therapy (cycles 1 - 8)

Primary Outcome Measures

Name	Time	Method
Time to treatment failure	5 years

Secondary Outcome Measures

Name	Time	Method
Overall survival	5 years
Adverse event and safety profile	5 years
Quality of life	5 years
Complete response rate in patients with carcinoma in situ	5 years
Time to recurrence	5 years
Time to progression	5 years

Trial Locations

Locations (6)

Clinical Research Unit at Vancouver Coastal; 🇨🇦 Vancouver, British Columbia, Canada

CHUQ-Pavillon Hotel-Dieu de Quebec; 🇨🇦 Quebec City, Quebec, Canada

Centre hospitalier universitaire de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada

Hamilton and District Urology Association; 🇨🇦 Hamilton, Ontario, Canada

London Regional Cancer Program; 🇨🇦 London, Ontario, Canada

Univ. Health Network-Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada