NCT00227708已完成2 期
Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy Regimen With Bi-Weekly Docetaxel in the Treatment of Metastatic or Locally Advanced Non-Small Cell Lung Cancer in Patients Over the Age of 70
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 58
- 试验地点
- 9
- 主要终点
- Quality of life
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. Chemotherapy drugs may have different effects in older patients.
PURPOSE: This phase II trial is studying how well docetaxel works in treating older patients with locally advanced or metastatic non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the quality of life of older patients with locally advanced or metastatic non-small cell lung cancer treated with docetaxel.
Secondary
- Determine the response rate in patients treated with this drug.
- Determine the overall survival and progression-free survival of patients treated with this drug.
- Determine the mood status and autonomy of activity of patients treated with this drug.
- Determine the 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 120 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed non-small cell lung cancer, including adenocarcinoma, squamous cell carcinoma, large cell carcinoma, or combination of these histologies
- •Stage IIIB (i.e., pleural T4) disease
- •Stage IV disease
- •Recurrent disease after prior surgery or radiotherapy allowed provided disease is in an area that was not previously irradiated
- •Measurable disease by CT scan or MRI
- •No symptomatic brain metastasis
- •Activity of Daily Living Scale score ≥ 4
- •Instrumental Autonomy of Daily Living Scale score ≥ 4
- •PATIENT CHARACTERISTICS:
- •70 and over
- •Performance status
- •Not specified
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •Neutrophil count > 1,500/mm^3
- •Platelet count > 100,000/mm^3
- •Hemoglobin > 10 g/dL
- •Transaminases < 1.5 times normal
- •Bilirubin normal
- •Alkaline phosphatase < 2.5 times normal
- •Pre-albumin > 1.5 mg/dL
- •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 uncontrolled high-risk arrhythmias
- •Gastrointestinal
- •No active peptic ulcer
- •No inflammatory bowel disease
- •No history of dementia or seizures that would preclude giving informed consent
- •No peripheral neuropathy ≥ grade 2
- •No history of significant neurologic disorders
- •Immunologic
- •No history of hypersensitivity to the study drug or drugs formulated with polysorbate 80
- •No active uncontrolled infection
- •No history of psychotic disorders
- •No uncontrolled diabetes mellitus
- •No absolute contraindication to corticosteroid use
- •No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
- •No geriatric depression scale score ≥ 12/15
- •No familial, social, geographical, or psychological reason that would preclude study follow up
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy for stage IIIB or IV non-small cell lung cancer
- 另有 9 项未显示
排除标准
- 未提供
结局指标
主要结局
Quality of life
次要结局
- Response rate
- Overall survival
- Toxicity
- Progression-free survival
- Mood status and autonomy of activity
研究者
研究点 (9)
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