NCT00075517Unknown2 期
Phase II Study Of Gemcitabine And Docetaxel In Patients With Inoperable Stage IIIB Or IIIB or IV Non-Small Cell Lung Cancer
GERCOR - Multidisciplinary Oncology Cooperative Group24 个研究点 分布在 1 个国家开始时间: 2003年9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
- 主要终点
- Response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, 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: This phase II trial is studying how well giving gemcitabine together with docetaxel works in treating patients with inoperable stage IIIB or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the response rate in patients with inoperable stage IIIB or IV non-small cell lung cancer treated with gemcitabine and docetaxel.
Secondary
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the tolerance profile of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
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
- 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 or cytologically confirmed non-small cell lung cancer of 1 of the following histologic subtypes:
- •Epidermoid carcinoma
- •Large cell carcinoma
- •Adenocarcinoma
- •Stage IIIB (T4, any N, M0 OR any T, N3, M0) OR Stage IV disease
- •Inoperable disease
- •Measurable disease
- •At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •No symptomatic brain metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Platelet count at least 100,000/mm^3
- •Absolute neutrophil count at least 2,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Bilirubin no greater than normal
- •Transaminases no greater than 1.5 times normal
- •Alkaline phosphatase no greater than 2.5 times normal
- •Creatinine no greater than 2.3 mg/dL
- •Cardiovascular
- •No uncontrolled cardiac insufficiency
- •Not pregnant or nursing
- •Fertile patients must use effective contraception during and for 6 months after study therapy
- •No uncontrolled infection
- •No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
- •No grade 3 or 4 brain disorder
- •No intolerance to polysorbate 80 or cortisones
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy, including taxanes or gemcitabine
- •No other concurrent chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy to more than 20% of the bone marrow
- •No prior radiotherapy for lung cancer
- •At least 4 weeks since other prior radiotherapy and recovered
- •No prior surgery for lung cancer
- •More than 30 days since prior clinical trial participation
排除标准
- 未提供
结局指标
主要结局
Response rate
次要结局
- Overall survival
- Tolerability
- Quality of life
- Progression-free survival
研究者
研究点 (24)
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