NCT00025493终止2 期
Single Agent Docetaxel for Metastatic Breast Cancer in Patients Aged 70 Years and Older (and in a Cohort of Patients Younger Than 60 Years)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 27
- 主要终点
- Study treatment feasibility
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.
PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating older women who have metastatic breast cancer.
详细描述
OBJECTIVES:
- Determine the feasibility of treating elderly women with metastatic breast cancer with docetaxel.
- Determine the overall survival, 2-year survival, and response (confirmed and unconfirmed complete and partial) in patients treated with this drug.
- Determine the toxicity and tolerability of this drug in these patients.
- Determine the feasibility of using standardized self-report measures of comorbidity, depression, and functional status in elderly cancer patients.
- Determine the parameters of clinical pharmacology of this drug in elderly patients and in patients under 60 years of age.
- Determine, preliminarily, the genetic polymorphisms and gene expression levels of enzymes involved in drug metabolism and resistance in patients treated with this drug.
OUTLINE: Patients are stratified according to age (70 and over vs under 60).
Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 3 years.
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
- Female
- 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
docetaxel
Experimental
docetaxel
干预措施: docetaxel (Drug)
结局指标
主要结局
Study treatment feasibility
时间窗: monthly for duration of accrual
次要结局
- Overall survival(at weeks 10 and 19, then every 3 months for 3 years)
- Survival at 2 years(at weeks 10 and 19, then every 3 months for 2 years)
- Response rate (confirmed and unconfirmed complete and partial response)(at weeks 10 and 19, then every 3 months for 3 years)
- Toxicity and tolerability(at week 1, then every 3 weeks)
- Feasibility of standardized self-report measures of comorbidity, depression, and functional status(upon completion of patient accrual)
- Comparison of clinical pharmacologic parameters between elderly patients and patients under 60 years of age(upon completion of patient accrual)
研究者
相似试验
已完成
1 期
Combination Chemotherapy as Induction Therapy in Treating Patients With Stage III Non-small Cell Lung CancerLung CancerNCT00003037Memorial Sloan Kettering Cancer Center
终止
2 期
Docetaxel in Treating Patients With Recurrent or Refractory Ovarian or Primary Peritoneal CancerPrimary Peritoneal Cavity CancerOvarian CancerNCT00004037Gynecologic Oncology Group
已完成
2 期
Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast CancerBreast CancerNCT00004906Hackensack Meridian Health
已完成
1 期
Docetaxel and Flavopiridol in Treating Patients With Locally Advanced or Metastatic Breast CancerBreast CancerNCT00020332National Cancer Institute (NCI)
已完成
2 期
Docetaxel With or Without Thalidomide in Treating Patients With Metastatic Prostate CancerStage IV Prostate CancerAdenocarcinoma of the ProstateRecurrent Prostate CancerNCT00020046National Institutes of Health Clinical Center (CC)