NCT00006118Unknown2 期
First Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma of the Bladder With a Combination of Cisplatin-Paclitaxel-Gemcitabine
GERCOR - Multidisciplinary Oncology Cooperative Group24 个研究点 分布在 2 个国家开始时间: 1999年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 24
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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining cisplatin, paclitaxel, and gemcitabine in treating patients who have progressive unresectable regional or metastatic bladder cancer.
详细描述
OBJECTIVES:
- Determine the efficacy and toxicity of cisplatin, paclitaxel, and gemcitabine in patients with progressive unresectable regional or metastatic transitional cell carcinoma of the bladder.
- Determine the progression free survival of these patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes on days 1 and 8, and cisplatin IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 3 weeks for 6 courses.
Patients are followed every 3 months until disease progression.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically proven progressive unresectable regional or metastatic transitional cell carcinoma of the bladder
- •Measurable disease by CT or MRI scan
- •Greater than 10 mm
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 150,000/mm^3
- •Not specified
- •Creatinine less than 1.36 mg/dL
- •Cardiovascular:
- •No uncontrolled cardiac disease
- •No severe cardiac arrhythmias
- •Not pregnant or nursing
- •No other prior malignancy except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Prior intravesical immunotherapy for superficial disease allowed
- •No prior systemic biologic response modifier therapy for advanced disease
- •Chemotherapy:
- •Prior intravesical chemotherapy for superficial disease allowed
- •No prior systemic chemotherapy for advanced disease
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Prior radiotherapy allowed
- •No prior surgery
排除标准
- 未提供
研究者
研究点 (24)
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