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

Phase 1

Completed

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: celecoxib, gefitinib

• Registration Number: NCT00212108
• Lead Sponsor: National University Hospital, Singapore

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-21
• Primary Completion: 2007-03
• Study Completion: 2009-01
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-29
• Last Update Posted: 2012-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Histologically proven NPC.
2. Any clinical stage NPC as defined by the AJCC/UICC System.
3. No prior radiotherapy, chemoradiotherapy, immunotherapy or investigational agents.
4. No prior NSAIDs or corticosteroids for at least 4 weeks.
5. ECOG performance status ≤ 2.
6. Adequate end organ function
7. Life expectancy > 3 months.
8. Signed informed consent -

Exclusion Criteria

1. Inability to take celecoxib and gefitinib for the specified period of time (14 days) prior to definitive therapy.
2. Tumor not visible on fibre nasopharyngoscopy for biopsy.
3. Known peptic ulcer disease.
4. Evidence of clinically active interstitial lung disease.
5. 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.
6. 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.
7. Women of childbearing potential who are not practising adequate contraception.
8. Concurrent medical problems that would significantly limit compliance with the study.
9. 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.
10. 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.
11. Known HIV, HBV or HCV infection. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Celecoxib and ZD1839	celecoxib, gefitinib	Celecoxib and ZD1839 will be given twice a day and daily respectively for two consecutive weeks prior to further anti-cancer treatment.

Primary Outcome Measures

Name	Time	Method
To study histopathological changes in tumor following inhibition with celecoxib and gefitinib.	1 year

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety profile of celecoxib and ZD1839.	30 days
To assess the pharmacokinetics of ZD1839 and celecoxib.	30 days

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore