NCT00104793已完成2 期
Phase II Study of Weekly Irinotecan and Carboplatin in Extensive-Stage Small-Cell Lung Cancer
Japan Multinational Trial Organization22 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2003年6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
- 发起方
- 入组人数
- 55
- 试验地点
- 22
- 主要终点
- Response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as irinotecan and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving irinotecan together with carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving irinotecan together with carboplatin works in treating patients with newly diagnosed extensive-stage small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the response rate in patients with newly diagnosed, previously untreated extensive stage small cell lung cancer treated with irinotecan and carboplatin.
Secondary
- Determine the progression-free and overall survival 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed small cell lung cancer
- •Extensive stage disease
- •Newly diagnosed, treatment-naive disease
- •At least 1 unidimensionally measurable lesion
- •No massive pleural or pericardial effusion by chest CT scan
- •Manageable effusions allowed
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •More than 3 months
- •Hematopoietic
- •WBC ≥ 3,000/mm^3
- •Absolute granulocyte count ≥ 1,500/mm^3
- •Hemoglobin ≥ 9.0 g/dL
- •ALT or AST ≤ 2 times upper limit of normal
- •Bilirubin ≤ 1.5 mg/dL
- •Creatinine normal
- •Cardiovascular
- •No myocardial infarction within the past year
- •No uncontrolled hypertension
- •No unstable angina
- •No congestive heart failure
- •No ventricular arrhythmia requiring medical intervention
- •No other serious cardiovascular disease
- •Arterial oxygen pressure (Pa O_2) ≥ 70 mm Hg
- •No interstitial pneumonitis or pulmonary fibrosis by chest x-ray
- •Not pregnant or nursing
- •No uncontrolled diabetes
- •No severe infection
- •No paralytic or obstructive ileus
- •No serious diarrhea
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix that is in complete remission
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •Not specified
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No prior radiotherapy to the chest
- •Other prior radiotherapy allowed
- •At least 2 weeks since prior surgery and recovered
排除标准
- 未提供
结局指标
主要结局
Response
次要结局
- Survival
- Progression-free survival
研究者
研究点 (22)
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