NCT00005868已完成2 期
Taxotere and Cisplatin as Induction Chemotherapy in Patients With Stage IIIa N2 Non Small Cell Lung Cancer (NSCLC)
European Organisation for Research and Treatment of Cancer - EORTC46 个研究点 分布在 5 个国家目标入组 47 人开始时间: 2000年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 46
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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of docetaxel and cisplatin in treating patients who have untreated stage IIIA non-small cell lung cancer.
详细描述
OBJECTIVES:
- Assess the therapeutic activity of docetaxel and cisplatin in patients with untreated stage IIIA non-small cell lung cancer.
- Determine the safety of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on day 1 and cisplatin IV over 30 minutes on days 1 and 2. Treatment continues every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed stage IIIA non-small cell lung cancer (NSCLC) (T1-3, N2, M0)
- •Unresectable metastasis to ipsilateral mediastinal and/or subcarinal lymph nodes
- •Measurable disease
- •Must be at least 20 mm in one dimension by conventional techniques or at least 10 mm by spiral CT scan
- •No distant metastases
- •No CNS involvement
- •No pleural or pericardial effusion
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than upper limit of normal (ULN)
- •AST/ALT no greater than 1.5 times ULN
- •Alkaline phosphatase no greater than 2.5 times ULN
- •Creatinine no greater than 1.25 ULN
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No superior vena cava syndrome
- •No uncontrolled congestive heart failure or angina
- •No myocardial infarction within past year
- •No uncontrolled hypertension or arrhythmia
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No concurrent active infection requiring IV antibiotic therapy
- •No other prior malignancy in past 5 years except carcinoma in situ of the cervix or adequately treated basal cell carcinoma, excluding melanoma, breast cancer, and hypernephroma
- •No concurrent illness or medical condition which is a contraindication for corticosteroid therapy (e.g., active ulcer, unstable diabetes mellitus)
- •No motor or sensory neurotoxicity of grade 2 or greater
- •No psychological, familial, sociological, or geographical condition that would preclude study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •No concurrent immunotherapy
- •Chemotherapy:
- •No prior chemotherapy for NSCLC
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •No concurrent hormonal therapy
- •Radiotherapy:
- •No prior radiotherapy for NSCLC
- •No concurrent radiotherapy
- •No prior surgery for NSCLC
- •At least 1 month since prior investigational agents
- •No other concurrent experimental medications
排除标准
- 未提供
研究者
研究点 (46)
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