NCT00212108已完成1 期
A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- To study histopathological changes in tumor following inhibition with celecoxib and gefitinib.
研究概览
简要总结
EGFR and COX-2 are involved in tumorigenesis, angiogenesis and metastases and are frequently over expressed in NPC.COX-2 and EGFR inhibitors are active in NPC.There is synergistic action between COX-2 and EGFR inhibitors.
Study hypothesis: Celecoxib and gefitinib can reduce angiogenesis and induce anti-tumorigenicity in patients with nasopharngeal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Histologically proven NPC.
- •Any clinical stage NPC as defined by the AJCC/UICC System.
- •No prior radiotherapy, chemoradiotherapy, immunotherapy or investigational agents.
- •No prior NSAIDs or corticosteroids for at least 4 weeks.
- •ECOG performance status ≤
- •Adequate end organ function
- •Life expectancy > 3 months.
- •Signed informed consent -
排除标准
- •Inability to take celecoxib and gefitinib for the specified period of time (14 days) prior to definitive therapy.
- •Tumor not visible on fibre nasopharyngoscopy for biopsy.
- •Known peptic ulcer disease.
- •Evidence of clinically active interstitial lung disease.
- •Previous or concomitant malignancies with the exception of adequately treated carcinoma-in-situ of the cervix and basal or squamous cell carcinoma of the skin.
- •Women who are pregnant or lactating. Females with child-bearing potential must have a negative serum pregnancy test within 7 days prior to study enrolment.
- •Women of childbearing potential who are not practising adequate contraception.
- •Concurrent medical problems that would significantly limit compliance with the study.
- •Presence of any underlying medical conditions (eg. Unstable or uncompensated respiratory, cardiac, renal or hepatic disease) that in the opinion of the investigator would make the patient unsuitable for study participation.
- •Known hypersensitivity to celecoxib and gefitinib or any of the excipients of the products, known sulphonamide sensitivity and allergic reaction following the ingestion of NSAIDs.
- •Known HIV, HBV or HCV infection. -
研究组 & 干预措施
Celecoxib and ZD1839
Experimental
Celecoxib and ZD1839 will be given twice a day and daily respectively for two consecutive weeks prior to further anti-cancer treatment.
干预措施: celecoxib, gefitinib (Drug)
结局指标
主要结局
To study histopathological changes in tumor following inhibition with celecoxib and gefitinib.
时间窗: 1 year
次要结局
- To evaluate the safety profile of celecoxib and ZD1839.(30 days)
- To assess the pharmacokinetics of ZD1839 and celecoxib.(30 days)
研究者
Haematology-Oncology
Dr. Ross Soo
National University Hospital, Singapore
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Trial of Endostar in Combination With Chemotherapy of DF and Sequential Intensity Modulated Radiation Therapy for Patients With Advanced Nasopharyngeal CarcinomaNasopharyngeal NeoplasmsNCT02444949China Three Gorges University, Yichang, China75
Unknown
不适用
Hypoxia Imaging -Guided Radiotherapy of Nasopharyngeal CarcinomaNasopharyngeal CarcinomaNCT02089204Xuzhou Medical University300
已完成
不适用
Prognostic Utility of the Imaging and Biological Signatures in Nasopharyngeal CarcinomaNasopharyngeal CarcinomaNCT04417985Chang Gung Memorial Hospital112
已完成
2 期
Carboplatin and Docetaxel Followed by Epstein-Barr Virus Cytotoxic T LymphocytesNasopharyngeal CarcinomaNCT00953420Baylor College of Medicine20
Unknown
不适用
Investigating the Role of Mucin and Mucin Glycosylating Enzymes in Nasopharyngeal Carcinoma and Salivary Gland Cancer and Their Correlation With Clinical PrognosisSalivary Gland CancerNasopharyngeal CarcinomaNCT02401763National Taiwan University Hospital200