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
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 6
- 主要终点
- Time to treatment failure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Intravesicle BCG
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)
干预措施: BCG vaccine (Biological)
Intravesicle BCG
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)
干预措施: quality-of-life assessment (Procedure)
Iressa and Intravesicle BCG
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)
干预措施: BCG vaccine (Biological)
Iressa and Intravesicle BCG
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)
干预措施: gefitinib (Drug)
Iressa and Intravesicle BCG
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)
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Time to treatment failure
时间窗: 5 years
次要结局
- 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)