NCT00004883已完成2 期
A Phase II Trial of Trastuzumab (Herceptin) for Advanced Stage (IIIB, IV), HER2 Overexpressing, Non-Small Cell Lung Cancer
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Response rate (complete response [CR] and partial response [PR])
研究概览
简要总结
Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage IIIB or stage IV non-small cell lung cancer that overexpresses HER2. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
详细描述
PRIMARY OBJECTIVES:
I. Determine the activity of trastuzumab (Herceptin) in patients with stage IIIB or IV HER2-overexpressing non-small cell lung cancer.
SECONDARY OBJECTIVES:
I. Determine the duration of response in patients treated with this regimen. II. Determine the toxicity of this treatment regimen in this patient population.
III. Assess levels of circulating HER2 and correlate with HER2 expression in this patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Histologically confirmed stage IIIB or IV non-small cell lung cancer
- •Supraclavicular node involvement allowed
- •Malignant pleural effusion allowed (cytological confirmation not required if pleural fluid bloody or exudative)
- •No stage IIIB patients eligible for CLB protocols comprising combined chemotherapy and chest radiotherapy
- •Recurrent disease allowed
- •HER2 overexpression (2-3+)
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm by conventional techniques
- •At least 10 mm by spiral CT scan
- •The following are not considered measurable:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Abdominal masses not confirmed and followed by imaging
- •Cystic lesions
- •No CNS metastases
- •Performance status - ECOG 0-2
- •Granulocyte count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •Creatinine no greater than 1.5 times ULN
- •LVEF at least 45% (by echocardiogram or MUGA)
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •HIV negative
- •No concurrent immunologic disease (e.g., autoimmune disease)
- •No history of allergy to murine products
- •No prior murine antibodies
- •No prior anthracyclines
- •No more than 1 prior chemotherapy regimen for lung cancer
- •At least 4 weeks since prior chemotherapy
- •No concurrent chemotherapy
- •No concurrent steroids except for adrenal failure or dexamethasone as an antiemetic
- •No concurrent hormonal therapy except for nondisease-related conditions (e.g., insulin for diabetes)
- •At least 6 months since prior radiotherapy
- •No concurrent palliative radiotherapy
- •At least 4 weeks since prior major surgery
排除标准
- 未提供
结局指标
主要结局
Response rate (complete response [CR] and partial response [PR])
时间窗: Up to 5 years
次要结局
- Overall survival (OS)(From registration until death or last known follow-up, assessed up to 5 years)
- Failure-free survival (FFS)(Time between registration and disease progression, death, or last known follow-up, assessed up to 5 years)
- Duration of response(Time between the initial documentation of response and subsequent failure (death, disease progression), assessed up to 5 years)
- Toxicity as assessed by NCI's Common Toxicity Criteria(Up to 5 years)
- Relationship between HER2 expression in tumor tissue and serum(Up to 5 years)
研究者
研究点 (2)
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