NCT00072072已完成1 期
A Phase I Trial Of A COX-2 Inhibitor (Celecoxib) In Combination With An EGFR Inhibitor (OSI-774) In Metastatic Non-Small Cell Lung Cancer
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
研究概览
简要总结
RATIONALE: Celecoxib may stop the growth of cancer by stopping blood flow to the tumor. Erlotinib and celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining celecoxib with erlotinib may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib when given together with erlotinib in treating patients with stage IIIB or stage IV non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Determine the biologically active dose of celecoxib administered with erlotinib in patients with stage IIIB or IV non-small cell lung cancer.
- Determine the toxicity profile of this regimen in these patients.
Secondary
- Determine the clinical activity of this regimen, in terms of reduction in tumor burden, in these patients.
- Correlate biological endpoints with cyclooxygenase-2 and epidermal growth factor receptor inhibition in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- 21 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 lung cancer (NSCLC)
- •Stage IIIB or IV
- •Measurable disease
- •Progressive disease after at least 2 prior standard chemotherapy regimens OR refused standard chemotherapy
- •No active CNS metastases
- •PATIENT CHARACTERISTICS:
- •21 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •Transaminases no greater than 2.5 times upper limit of normal (ULN)
- •PT and/or PTT no greater than 1.5 times ULN
- •Creatinine no greater than 2 mg/dL
- •Cardiovascular
- •No New York Heart Association class III or IV cardiac disease
- •No myocardial infarction within the past year
- •No symptomatic ventricular arrhythmia
- •No symptomatic conduction abnormality
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior gastrointestinal ulceration, bleeding, or perforation
- •No hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or other reagents used in this study
- •No concurrent disease or medical condition that would preclude study treatment or compliance
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •More than 4 weeks since prior chemotherapy
- •Endocrine therapy
- •More than 4 weeks since prior corticosteroids
- •No concurrent steroids (including chronic use)
- •Concurrent topical steroids allowed
- •Radiotherapy
- •More than 4 weeks since prior radiotherapy
- •Not specified
- •More than 4 weeks since prior non-cytotoxic investigational agents
- •More than 3 days since prior nonsteroidal anti-inflammatory drugs (NSAIDs)
- •No prior cyclooxygenase-2 (COX-2) inhibitors for metastatic NSCLC
- •No prior epidermal growth factor receptor inhibitor for metastatic NSCLC
- •No concurrent COX-2 inhibitors
- •No concurrent NSAIDs
- •No concurrent fluconazole or lithium
排除标准
- 未提供
研究者
研究点 (1)
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