NCT00998101撤回2 期
A Phase II Trial of Carboplatin, Ixabepilone and Cetuximab in Chemotherapy Naive Advanced Non-Small Cell Lung Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Disease-control rate after 2 courses of carboplatin, cetuximab, and ixabepilone
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as carboplatin and ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block cancer growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. Giving chemotherapy together with monoclonal antibodies may be a better way to block cancer growth.
PURPOSE: This phase II trial is studying the side effects and how well giving carboplatin and ixabepilone together with cetuximab works in treating patients with stage III or stage IV non-small cell lung cancer previously untreated with chemotherapy.
详细描述
OBJECTIVES:
Primary
- To estimate the disease-control rate in patients with advanced chemotherapy-naive non-small cell lung cancer after 2 courses of carboplatin, ixabepilone, and cetuximab.
Secondary
- To estimate the progression-free survival of patients treated with this regimen.
- To estimate the overall survival of patients treated with this regimen.
- To estimate the toxicity of this regimen in these patients.
- To determine the potential predictive marker of efficacy of ixabepilone and cetuximab. (exploratory)
- To investigate the prevalence of cetuximab IgE antibody, and the rate of cetuximab hypersensitivity reactions in patients without evidence of cetuximab IgE antibodies.
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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed non-small cell lung cancer
- •Chemotherapy-naive
- •Stage IIIB disease not amenable to surgery with pleural effusion, pericardial effusion, or not a candidate for chemoradiotherapy
- •Stage IV disease
- •Must have pathology block or unstained slides from initial or subsequent diagnosis
- •Diagnosis made via a core biopsy (not a fine-needle aspirate) required
- •Measurable disease as defined by RECIST guidelines
- •For patient who received prior radiotherapy, evaluable disease must be outside of the radiation field, or have new lesions that developed within the radiation field
- •Brain metastasis allowed provided it has been treated and determined to be controlled by the treating physician
- •No IgE cetuximab antibody
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •ANC ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 8.0 g/dL
- •Creatinine < 2.0 times upper limit of normal (ULN)
- •AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of hepatic metastasis)
- •Bilirubin ≤ 1.5 times ULN
- •Prior malignancy allowed provided the treating physician determines that the patient's life expectancy is best defined by diagnosis of non-small cell lung cancer (NSCLC)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No peripheral neuropathy ≥ grade 2 by NCI CTCAE v. 3.0
- •No prior severe allergic reaction to any of the following:
- •Carboplatin
- •Taxane therapy
- •Monoclonal antibody
- •Hypersensitivity (NCI CTCAE grade3-4) to a drug formulated in Cremophor® EL (polyoxyethylated castor oil)
- •No active or uncontrolled infection
- •No significant history of uncontrolled cardiac disease including, but not limited to, any of the following:
- •Uncontrolled hypertension
- •Unstable angina
- •Myocardial infarction within the past 6 months
- •Uncontrolled congestive heart failure
- •Cardiomyopathy with decreased ejection fraction
- •No underlying interstitial lung disease
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •At least 1 week since prior and no concurrent therapeutic radiotherapy
- •Palliative radiotherapy for painful bone lesions allowed
- •At least 6 months since prior adjuvant chemotherapy
- •No investigational agent(s) within the past 30 days
- •Not requiring concurrent treatment with any of the following:
- •Ketoconazole
- •Itraconazole
- •Ritonavir
- •Amprenavir
- •Indinavir
- •Nelfinavir
- 另有 3 项未显示
排除标准
- 未提供
结局指标
主要结局
Disease-control rate after 2 courses of carboplatin, cetuximab, and ixabepilone
时间窗: 42 days
Disease control rate will be defined as patients experiencing a complete or partial response or stable disease (radiographic response) measured by RECIST criteria.
次要结局
- Progression-free survival(2 years)
- Overall survival(4 years)
- Number of subjects experiencing adverse events(1 year)
研究者
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