Protocol for Assessment of Gemcitabine and Paclitaxel for Metastatic Urothelial Cancer in Patients Aged 70 Years or Older (and in a Cohort of Patients Younger Than 60 Years)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 92
- 主要终点
- Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols
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. Giving more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and paclitaxel in treating patients who have advanced or recurrent cancer of the urinary tract.
详细描述
OBJECTIVES:
- Determine the feasibility of enrolling patients aged 70 years and older with advanced or recurrent urothelial cancer to a structured phase II study.
- Determine the anticancer efficacy of gemcitabine and paclitaxel, in terms of objective response rate and 2-year survival, in these elderly patients.
- Assess the toxicity and tolerability of this regimen in these elderly patients.
- Determine the feasibility of using standardized self-report measures of comorbidity, depression, and functional status in these patients.
- Determine the pharmacokinetics of this regimen in these elderly patients and validate this data against similar parameters in patients aged under 60 years.
OUTLINE: This is a multicenter study. Patients are stratified according to age (70 and over vs under 60).
Patients receive paclitaxel IV over 3 hours on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline.
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
- — 至 120 Years（Child, 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
gemcitabine, paclitaxel
干预措施: gemcitabine hydrochloride (Drug)
gemcitabine, paclitaxel
干预措施: paclitaxel (Drug)
结局指标
主要结局
Determine the Feasibility of Accruing Patients With Metastatic Bladder Cancer Who Are 70 and Older to Chemotherapy Protocols
时间窗: 66 months (protocol activated on 7/1/2001 and closed to accrual on 12/15/2006)
Sixty patients aged 70 years and older were to be accrued to the study. The feasibility of accrual was determined that accrual of 3 patients per month in the age 70 and older range would allow for an expeditiously conducted phase II trial. If, after a 3 month start-up period, 3 or more patients aged 70 years and older were accrued per month for the duration of the trial, it was deemed reasonable to consider further trials in this elderly population.
次要结局
- Progression-free Survival in Patients Aged 70 Years and Older(0-5 years)
- Overall Survival (OS) in Patients Aged 70 Years and Older(0-5 years)
- Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug(Patients were assessed for adverse events weekly after protocol treatment for cycle 1 (1 cycle = 21 days) and then weekly for the first 2 weeks of protocol treatment for cycle 2-6 and after completion of protocol treatment.)
- Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Median Time of Complete Forms(at study entry (prior to administration of any treatment))
- Assess the Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: at Least One Type of Assistance Required(at study entry (prior to administration of any treatment))
- Overall Confirmed Response Rate in the Patients Age 70 and Older (Complete and Partial Response)(every week for the first 4 weeks and then every 3 weeks for up to 19 weeks)
- Feasibility of Patient-reported Outcome Measures for Patients Aged 70 Years and Older: Form Submission Rate(at study entry (prior to administration of any treatment))