NCT00104624终止2 期
Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy With Biweekly Docetaxel in the Treatment of Metastatic Breast Cancer in Patients Over 70
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- UNICANCER
- 入组人数
- 53
- 试验地点
- 7
- 主要终点
- Degree of autonomy in instrumental activities of daily living as measured by Lawton's Instrumental Activities of Daily Living Scale during therapy and at 6 and 12 months
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well docetaxel works in treating older women with metastatic breast cancer and whether it helps improve the ability to perform daily activities.
详细描述
OBJECTIVES:
Primary
- Determine degree of autonomy in instrumental activities of daily living on-therapy and at 6 and 12 months, as measured by Lawton's Instrumental Activities of Daily Living Scale, in older women with metastatic adenocarcinoma of the breast treated with docetaxel.
Secondary
- Determine the response rate in patients treated with this drug.
- Determine overall and progression-free survival of patients treated with this drug.
- Determine the degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale, in patients treated with this drug.
- Determine mood status, as measured by the Geriatric Depression Scale, of patients treated with this drug.
- Determine toxicity of this drug in these patients.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed adenocarcinoma of the breast
- •Metastatic disease
- •Measurable disease by CT scan or MRI
- •Requires first-line chemotherapy for metastatic disease
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •70 and over
- •Menopausal status
- •Not specified
- •Performance status
- •Meets both of the following criteria:
- •Lawton's Instrumental Activities of Daily Living score ≥ 4
- •Katz's Activities of Daily Living score ≥ 4
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •Hemoglobin > 10 g/dL
- •Neutrophil count > 1,500/mm^3
- •Platelet count > 100,000/mm^3
- •ALT and AST < 1.5 times normal
- •Bilirubin normal
- •Alkaline phosphatase < 2.5 times normal
- •Creatinine clearance > 30 mL/min
- •Cardiovascular
- •No congestive heart failure
- •No unstable angina pectoris
- •No myocardial infarction within the past year
- •No uncontrolled hypertension
- •No high-risk uncontrolled arrhythmias
- •Geriatric Depression Score < 12
- •No active uncontrolled infection
- •No active peptic ulcer
- •No uncontrolled diabetes mellitus
- •No inflammatory bowel disease
- •No history of hypersensitivity to docetaxel or drugs formulated with polysorbate 80
- •No history of significant neurologic or psychiatric disorders, including psychotic disorders, dementia, or seizures, that would preclude giving informed consent
- •No familial, social, geographical, or psychological condition that would preclude study follow-up
- •No definite contraindication to corticosteroids
- •No other serious illness or medical condition
- •No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior or concurrent trastuzumab (Herceptin^®)
- •Chemotherapy
- •Prior neoadjuvant or adjuvant chemotherapy for breast cancer allowed
- •More than 2 years since prior docetaxel or paclitaxel
- •No other concurrent chemotherapy
- •Endocrine therapy
- 另有 12 项未显示
排除标准
- 未提供
结局指标
主要结局
Degree of autonomy in instrumental activities of daily living as measured by Lawton's Instrumental Activities of Daily Living Scale during therapy and at 6 and 12 months
次要结局
- Response rate
- Toxicity
- Overall survival
- Degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale
- Progression-free survival
- Mood status as measured by the Geriatric Depression Scale
研究者
研究点 (7)
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