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

National University Hospital, Singapore1 site in 1 country22 target enrollmentNovember 2003

ConditionsNasopharyngeal Carcinoma

Interventionscelecoxib, gefitinib

Drugscelecoxib, gefitinib

Overview

Phase: Phase 1
Intervention: celecoxib, gefitinib
Conditions: Nasopharyngeal Carcinoma
Sponsor: National University Hospital, Singapore
Enrollment: 22
Locations: 1
Primary Endpoint: To study histopathological changes in tumor following inhibition with celecoxib and gefitinib.
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2003

End Date

January 2009

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

National University Hospital, Singapore

Responsible Party

Principal Investigator

Haematology-Oncology

Dr. Ross Soo

National University Hospital, Singapore

Eligibility Criteria

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 ≤
•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.