A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839

Study Overview
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Brief Summary
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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.

Official Title
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A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: celecoxib, gefitinib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 ≤ 2. Adequate end organ function Life expectancy > 3 months. Signed informed consent - Exclusion Criteria: 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. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celecoxib and ZD1839<br>Celecoxib and ZD1839 will be given twice a day and daily respectively for two consecutive weeks prior to further anti-cancer treatment. | Drug: celecoxib, gefitinib<br>* The dose of ZD1839 to be administered is 250mg. ZD1839 will be taken once daily in the morning at approximately the same time each day. If the patient inadvertently did not take the dose in the morning, the patient may take that dose anytime up to 10pm that same day. The daily treatment will be resumed the next day at the scheduled morning dose. Celecoxib will be administered at 400 mg bd.<br>* Other names: ZD1839 (Iressa™);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study histopathological changes in tumor following inhibition with celecoxib and gefitinib. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety profile of celecoxib and ZD1839. |  | 30 days | 
| To assess the pharmacokinetics of ZD1839 and celecoxib. |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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celecoxib, NPC, gefitinib