CClinicalTrials.gg
CompletedNCT00212108Updated Apr 2, 2012

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

A Phase 1/2 interventional study of celecoxib, gefitinib in Nasopharyngeal Carcinoma, sponsored by National University Hospital, Singapore. Completed at 1 site in Singapore. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-04-02.

Sponsored by National University Hospital, Singapore · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
22
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Nasopharyngeal Carcinoma

Keywords

  • celecoxib, NPC, gefitinib
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 22 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

National University Hospital, Singapore is the lead sponsor of 444 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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. -
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Celecoxib and ZD1839

    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

Interventions

  • Drugcelecoxib, gefitinib

    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.

    Also known as: ZD1839 (Iressa™)

06

What researchers measure

Primary outcomes

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

    Time frame: 1 year

Secondary outcomes

  1. To evaluate the safety profile of celecoxib and ZD1839.

    Time frame: 30 days

  2. To assess the pharmacokinetics of ZD1839 and celecoxib.

    Time frame: 30 days

07

Study locations

1 site
  • National University Hospital
    Singapore, 119074, Singapore
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 2, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00212108
Lead sponsor
National University Hospital, Singapore
Collaborators
National Healthcare Group, Singapore
Responsible party
Haematology-Oncology (Dr. Ross Soo, National University Hospital, Singapore) — Principal investigator
First posted
Sep 21, 2005
Start date
Nov 2003
Primary completion
Mar 2007
Completion
Jan 2009
Last update
Apr 2, 2012

Study contacts

Ross Soo, MD
principal investigator · National University Hospital, Singapore
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion