NCT00293280已完成2 期
Phase II Study of CCNU (Lomustine) in Patients With Advanced Non-Small Cell Lung Cancer and Aberrant Hypermethylation of the MGMT Gene
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2005年7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
- 42
- 试验地点
- 1
- 主要终点
- Response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as lomustine, 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 lomustine works in treating patients with stage III or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Evaluate the response rate to lomustine in patients with stage IIIB or IV non-small cell lung cancer with aberrant methylation of the MGMT gene.
- Determine whether the response rate in these patients is significantly greater than that of the historical control.
Secondary
- Collect preliminary data on toxicity, disease stabilization, time to disease progression, and overall survival.
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 confirmed non-small cell bronchogenic carcinoma, including the following histologic subtypes:
- •Squamous cell
- •Adenocarcinoma
- •Adenosquamous
- •Large cell anaplastic
- •Bronchoalveolar
- •Non-small cell carcinoma not otherwise specified (NOS)
- •Stage IIIB disease (with a pleural effusion) or stage IV disease
- •Stage IV patients with brain metastases are eligible provided the brain metastases are clinically stable after treatment with surgery and/or radiation therapy
- •Tumors must test positive for aberrant methylation of the MGMT gene by methylation-specific polymerase chain reaction
- •Bidimensionally measurable or evaluable disease
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •No other active malignancies
- •WBC ≥ 4,000/mm^3 OR absolute neutrophil count ≥ 2,000/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Total bilirubin normal
- •AST < 5 times upper limit of normal
- •Serum creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min
- •No uncontrolled serious active infection
- •Not pregnant or nursing
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 3 weeks since prior chemotherapy
- •No more than 2 prior chemotherapy regimens
- •No prior therapy with nitrosoureas
- •Recovered from prior radiation therapy
排除标准
- 未提供
结局指标
主要结局
Response rate
次要结局
- Toxicity
- Disease stabilization
- Overall survival
- Time to disease progression
- Association between clinical outcome and immunohistochemical staining
研究者
研究点 (1)
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