NCT00081302已完成2 期
A Phase II Study Of Cetuximab (C225) In Combination With Chemoradiation In Patients With Stage IIIA/B Non-Small Cell Lung Cancer (NSCLC)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in 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. Giving cetuximab together with combination chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with paclitaxel, carboplatin, and radiation therapy works in treating patients with unresectable stage IIIA or stage IIIB non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the feasibility of cetuximab when administered concurrently with paclitaxel, carboplatin, and radiotherapy, in terms of safety and compliance, in patients with unresectable stage IIIA or IIIB non-small cell lung cancer.
Secondary
- Determine the response rate (complete and partial) in patients treated with this regimen.
- Determine the overall survival (1- and 2-year survival rate and median survival) of patients treated with this regimen.
- Determine the time to disease progression (at 1 and 2 years) in patients treated with this regimen.
- Correlate epidermal growth factor receptor expression with the toxicity of this regimen and response, overall survival, and progression in these patients.
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 non-small cell lung cancer (NSCLC) of 1 of the following subtypes:
- •Squamous cell carcinoma
- •Adenocarcinoma (including bronchoalveolar cell)
- •Large cell anaplastic carcinoma (including giant and clear cell carcinomas)
- •Poorly differentiated/not otherwise specified NSCLC
- •Stage IIIA (T1-2, N2, M0 or T3, N1-2, M0) or IIIB (T4, any N, M0 or any T, N2-3, M0)
- •If the largest mediastinal node is < 2.0 cm in diameter and this is the basis for stage III disease, then at least 1 of the nodes must be cytologically or histologically positive
- •Unresectable disease
- •No totally resected tumors
- •Tumors adjacent to a vertebral body allowed provided all gross disease can be encompassed in the radiation boost field and the boost volume is limited to < 50% of the ipsilateral lung volume
- •Measurable disease
- •Transudate, cytologically negative, non-bloody pleural effusions allowed provided the tumor can be encompassed within a reasonable field of radiotherapy
- •Pleural effusions seen on a chest CT scan are allowed provided they are not visible on a chest x-ray and are too small to tap
- •No asymptomatic or symptomatic brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status
- •Zubrod 0-1
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 9 g/dL (transfusion independent)
- •Bilirubin ≤ 1.5 mg/dL
- •SGOT (serum glutamic oxaloacetic transaminase) or SGPT (serum glutamate pyruvate transaminase) ≤ 3 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 2.5 times ULN
- •Creatinine ≤ 2.0 mg/dL
- •Cardiovascular
- •No significant history of cardiac disease
- •No uncontrolled hypertension
- •No unstable angina
- •No uncompensated congestive heart failure
- •No myocardial infarction within the past year
- •No cardiac ventricular arrhythmias requiring medication
- •LVEF (left ventricular ejection fraction) normal by MUGA (multi-gated acquisition) scan or echocardiogram
- •No history of interstitial pneumonitis
- •No history of severe chronic obstructive pulmonary disease requiring 3 or more hospitalizations within the past year
- •FEV_1 ≥ 1,200 cc
- •No active pulmonary infection unresponsive to conventional antibiotics
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 4 weeks after study therapy
- •Glucose ≤ 2 times ULN
- •No more than 5% weight loss within the past 3 months
- •No known allergy to murine proteins or Cremophor EL
- •No neuropathy grade 2 or greater
- •No other malignancy within the past 2 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other in situ cancers
- •PRIOR CONCURRENT THERAPY:
- 另有 20 项未显示
排除标准
- 未提供
研究者
研究点 (1)
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