NCT00357617Unknown1 期
Evaluation of the Effect of Celecoxib on Angiogenesis Markers in Patients With Operable Head and Neck Squamous Cell Carcinoma
适应症
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Molecular markers of angiogenesis in tumor tissues (PGE2, VEGF, MMP-9, sFlt-1, ERK phosphorylation, PKB phosphorylation, and ErbB2 levels)
研究概览
简要总结
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving celecoxib before surgery may reduce the amount of normal tissue that needs to be removed. Collecting and storing samples of tumor tissue, blood, and urine from patients with head and neck cancer to study in the laboratory may help doctors learn more about the cancer and predict how well patients will respond to treatment with celecoxib.
PURPOSE: This phase I/II trial is studying changes in tumor cells and how well celecoxib works in treating patients with head and neck cancer that can be removed by surgery.
详细描述
OBJECTIVES:
Primary
- Evaluate the changes in molecular markers of angiogenesis before and after treatment with celecoxib in tumor tissues of patients with resectable head and neck squamous cell carcinoma.
Secondary
- Evaluate the changes in molecular markers of angiogenesis before and after treatment with celecoxib in blood tissues of these patients.
- Evaluate the effects of celecoxib on indirect measures of tumor perfusion, as measured by perfusion CT scan, in these patients.
- Evaluate the effects of celecoxib on apoptosis and proliferation rate on tumor cells and on endothelial cells in these patients.
- Identify potential new markers of the activity of cyclooxygenase-2 inhibitors and identify new pathways of potential interests by performing gene expression profiling of tumor tissues before and after exposure to celecoxib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 confirmed or high clinical suspicion of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
- •No carcinoma of sinonasal or nasopharynx
- •Clinical stage T1-4, N0-2, M0 disease
- •Tumor must be considered resectable with planned surgical excision
- •No lymph nodes > 6 cm (N3)
- •No distant metastasis
- •PATIENT CHARACTERISTICS:
- •Absolute neutrophil count ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 10 g/dL
- •Creatinine ≤ 1.5 times upper limit of normal (ULN)
- •Creatinine clearance ≥ 60 mL/min
- •AST and ALT ≤ 2.5 times ULN
- •Bilirubin normal
- •History of prior malignancy allowed if there is no evidence of recurrence or metastases at the time of screening
- •No comorbidity that precludes operability
- •No known liver impairment
- •Known recent gastric or duodenal ulcer allowed if treated for > 6 weeks prior to study enrollment
- •No known hypersensitivity to celecoxib
- •No known allergic reactions to sulfonamides, aspirin, or other NSAIDs
- •No psychological, familial, sociological, or geographical condition that would interfere with study compliance and follow-up schedule
- •Not pregnant or nursing
- •Negative pregnancy test
- •PRIOR CONCURRENT THERAPY:
- •More than 2 months since prior and no other concurrent anticancer or investigational drugs
- •More than 2 weeks since prior and no other concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids
- •No prior radiotherapy to the head and neck region
- •No concurrent radiotherapy
- •No concurrent therapeutic anticoagulation
- •No concurrent administration of any of the following:
- •Other cyclooxygenase-2 inhibitors
- •Low-dose aspirin for cardiovascular prophylaxis allowed
- •Aluminum and magnesium-containing antacids
- •ACE inhibitors
- •Furosemide
- •Known inhibitors of P450 2C9 (e.g., fluconazole, fluoxetine, fluvoxamin, isoniazid, omeprazole)
- •Known inducers of P450 2C9 (e.g., rifampin)
- •Acenocoumarol
排除标准
- 未提供
结局指标
主要结局
Molecular markers of angiogenesis in tumor tissues (PGE2, VEGF, MMP-9, sFlt-1, ERK phosphorylation, PKB phosphorylation, and ErbB2 levels)
次要结局
- Molecular markers in plasma (VEGF, MMP-9, and sFlt1)
- Molecular marker in urine (PGE2)
- Apoptosis/proliferation in tumor cells and endothelial cells
- Gene expression profiling in fresh tumor tissues (Erb-B2, c-IAP-2, PAI-1, MAPK-4, integrin α V, N-CAM, caspase 6, ErbB2 transducer, angiopoietin like-2, interleukin-8, and MMP13)
- Tumor perfusion imaging by perfusion CT scan
研究者
研究点 (1)
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