Brief Title
A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839
Official Title
A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839
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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
To study histopathological changes in tumor following inhibition with celecoxib and gefitinib.
Secondary Outcome
To evaluate the safety profile of celecoxib and ZD1839.
Condition
Nasopharyngeal Carcinoma
Intervention
celecoxib, gefitinib
Study Arms / Comparison Groups
Celecoxib and ZD1839
Description: Celecoxib and ZD1839 will be given twice a day and daily respectively for two consecutive weeks prior to further anti-cancer treatment.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
22
Start Date
November 2003
Completion Date
January 2009
Primary Completion Date
March 2007
Eligibility Criteria
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. -
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ross Soo, MD, ,
Location Countries
Singapore
Location Countries
Singapore
Administrative Informations
NCT ID
NCT00212108
Organization ID
NP01/07/03
Responsible Party
Principal Investigator
Study Sponsor
National University Hospital, Singapore
Collaborators
National Healthcare Group, Singapore
Study Sponsor
Ross Soo, MD, Principal Investigator, National University Hospital, Singapore
Verification Date
March 2012