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

Phase 1/Phase 2
18 Years
Not Enrolling
Nasopharyngeal Carcinoma

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Trial Information

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

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. -

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To study histopathological changes in tumor following inhibition with celecoxib and gefitinib.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Ross Soo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Hospital, Singapore


Singapore: Health Sciences Authority

Study ID:




Start Date:

November 2003

Completion Date:

January 2009

Related Keywords:

  • Nasopharyngeal Carcinoma
  • celecoxib, NPC, gefitinib
  • Carcinoma
  • Nasopharyngeal Neoplasms