NCT00062270已完成1 期
Neoadjuvant Chemoradiotherapy (Gemcitabine/Cisplatin and Taxotere) With or Without Co-Administration of ZD 1839 (Iressa) for Stage IIIA (N2) and Selective Stage IIIB Non-Small Cell Lung Cancer: Phase I-II Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- Determine the tolerability and toxicity of gefitinib in combination with chest radiotherapy in patients with stage IIIA or stage IIIB non-small cell lung cancer.
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. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of the tumor. Combining chemotherapy and radiation therapy with gefitinib before surgery may shrink the tumor so that it can be removed during surgery.
PURPOSE: Phase I/II trial to compare the effectiveness of neoadjuvant chemoradiotherapy with or without gefitinib in treating patients who are undergoing surgery for stage III non-small cell lung cancer.
详细描述
OBJECTIVES: Phase I:
- Determine the tolerability and toxicity of gefitinib in combination with chest radiotherapy in patients with stage IIIA or stage IIIB non-small cell lung cancer.
Phase II:
- Compare the pathologic response (complete response and rate of downstaging) in patients treated with neoadjuvant chemoradiotherapy with vs without gefitinib.
- Compare the feasibility and toxicity profile of these regimens in these patients.
- Compare the resection rates, time to progression, and overall survival of patients treated with these regimens.
- Correlate the percent decline in the fludeoxyglucose F 18 standardized uptake value as measured by position emission tomography with pathologic response at resection, time to progression, and overall survival in patients treated with these regimens.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 120 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
- •Stage IIIA (T1-3, N2)
- •Positive (pathological) ipsilateral mediastinal node
- •Selective stage IIIB meeting all of the following criteria:
- •No pleural/pericardial effusion or superior vena cava syndrome
- •T4 due to invasion of carina, trachea, or mediastinal structures
- •Mediastinal N3 nodes (without supraclavicular or cervical adenopathy)
- •Proof of N2 or N3 status requires surgical staging of the mediastinum (mediastinoscopy, mediastinotomy, or exploration)
- •Expression of epidermal growth factor receptor (at least 1+) by immunohistochemistry
- •Measurable disease by contrast CT scan allowed
- •No bronchoalveolar cell carcinoma
- •No prior diagnosis of lung cancer
- •PATIENT CHARACTERISTICS:
- •19 and over
- •Performance status
- •ECOG 0-1 (0-2 if albumin is at least 0.85 times lower limit of normal and weight loss within 3 months before diagnosis is no greater than 10%)
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 150,000/mm^3
- •Hemoglobin at least 10 g/dL
- •Bilirubin normal
- •AST and ALT no greater than 2.5 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 2 times ULN
- •Alkaline phosphatase between 1.5-2 times ULN requires a negative bone scan for metastatic bone disease
- •Creatinine no greater than 1.4 mg/dL OR
- •Creatinine clearance at least 60 mL/min
- •No myocardial infarction within the past 3 months
- •No active angina
- •No unstable heart rhythms
- •No congestive heart failure
- •Post-resection predicted FEV_1% greater than 35%
- •Predicted FEV_1% is defined as FEV_1% times percent perfusion to uninvolved lung from quantitative lung V/Q scan report
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 6 weeks after study treatment
- •No other uncontrolled medical illness
- •No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
- •No grade 2 or greater peripheral neuropathy
- •No concurrent ocular inflammation or infection
- •No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
- •No known severe hypersensitivity reaction to gefitinib or any of its excipients
- •No prior severe allergic reaction to platinum-containing compounds or mannitol
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No concurrent growth factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF]) during chemotherapy
- •Chemotherapy
- •No prior chemotherapy for lung cancer
- 另有 14 项未显示
排除标准
- 未提供
结局指标
主要结局
Determine the tolerability and toxicity of gefitinib in combination with chest radiotherapy in patients with stage IIIA or stage IIIB non-small cell lung cancer.
次要结局
未报告次要终点
研究者
研究点 (1)
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