Phase II Trial of Paclitaxel, Cisplatin and Ifosfamide in Patients With Advanced Urothelial Tumors
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cisplatin, ifosfamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving drugs in different ways may kill more tumor cells.
PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with metastatic urinary tract cancer that cannot be treated with surgery.
详细描述
OBJECTIVES:
- Determine the efficacy of cisplatin, ifosfamide, and paclitaxel in patients with unresectable or metastatic urothelial cancer (nontransitional cell histologies).
OUTLINE: Patients receive paclitaxel IV over 3 hours and cisplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-3. Filgrastim (G-CSF) is administered subcutaneously daily beginning on day 6 and continuing through day 17 or until blood counts recover. Treatment continues every 3 weeks for a maximum of 6 courses in the absence of stable or progressive disease after completion of course 2 or complete response after completion of course 4.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 2 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •DISEASE CHARACTERISTICS:
- •Histologically proven unresectable or metastatic urothelial cancer
- •No transitional cell histologies
- •Bidimensionally measurable disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Karnofsky 60-100%
- •Hematopoietic:
- •WBC at least 3,500/mm^3
- •Platelet count greater than 150,000/mm^3
- •Bilirubin less than 2.0 mg/dL
- •Creatinine less than 1.5 mg/dL OR
- •Creatinine clearance greater than 55 mL/min
- •Cardiovascular:
- •No New York Heart Association class III or IV heart disease
- •No other concurrent malignancy except basal cell skin cancer
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior systemic chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •At least 3 weeks since prior radiotherapy
- •Not specified
排除标准
- 未提供
结局指标
主要结局
Efficacy
次要结局
未报告次要终点