Phase II Trial of Adjuvant Gemcitabine Plus Cisplatin With Amifostine Cytoprotection in Patients With Locally Advanced Bladder Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Side effects of cisplatin/gemcitabine in combination with amifostine
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as amifostine, may protect normal cells from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine, cisplatin, and amifostine following surgery in treating patients who have locally advanced bladder cancer.
详细描述
OBJECTIVES:
- Determine the toxicity of adjuvant gemcitabine and cisplatin with amifostine cytoprotection in patients with completely resected locally advanced bladder cancer.
- Compare recurrence rate in these patients when treated with this regimen to historical control patients who had a cystectomy performed by the same surgeon.
OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15, and cisplatin IV over 60 minutes and amifostine IV over 15 minutes on day 1. Treatment continues every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 19-42 patients will be accrued for this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（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
Administration of Cisplatin, Gemcitabine, and Amifostine
Subjects receive the study drug combination in 29-day cycles. Gemcitabine (1000 mg/m2) is given by IV infusion on Days 1, 8, and 15 of each cycle. Cisplatin (70 mg/m2) is given by IV infusion on Day 1 of each cycle. Immediately prior to each cisplatin infusion amifostine (910 mg/m2) will be given by IV infusion.
干预措施: amifostine trihydrate (Drug)
Administration of Cisplatin, Gemcitabine, and Amifostine
Subjects receive the study drug combination in 29-day cycles. Gemcitabine (1000 mg/m2) is given by IV infusion on Days 1, 8, and 15 of each cycle. Cisplatin (70 mg/m2) is given by IV infusion on Day 1 of each cycle. Immediately prior to each cisplatin infusion amifostine (910 mg/m2) will be given by IV infusion.
干预措施: cisplatin (Drug)
Administration of Cisplatin, Gemcitabine, and Amifostine
Subjects receive the study drug combination in 29-day cycles. Gemcitabine (1000 mg/m2) is given by IV infusion on Days 1, 8, and 15 of each cycle. Cisplatin (70 mg/m2) is given by IV infusion on Day 1 of each cycle. Immediately prior to each cisplatin infusion amifostine (910 mg/m2) will be given by IV infusion.
干预措施: gemcitabine hydrochloride (Drug)
Administration of Cisplatin, Gemcitabine, and Amifostine
Subjects receive the study drug combination in 29-day cycles. Gemcitabine (1000 mg/m2) is given by IV infusion on Days 1, 8, and 15 of each cycle. Cisplatin (70 mg/m2) is given by IV infusion on Day 1 of each cycle. Immediately prior to each cisplatin infusion amifostine (910 mg/m2) will be given by IV infusion.
干预措施: adjuvant therapy (Procedure)
结局指标
主要结局
Side effects of cisplatin/gemcitabine in combination with amifostine
时间窗: 4 months
次要结局
未报告次要终点