Clinical trial · Interventional
A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839
NCT00212108CI-TRIAL-00006640completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib, gefitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 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.
- interventionNames
- Drug: celecoxib, gefitinib
Primary outcomes (1)
- measure
- To study histopathological changes in tumor following inhibition with celecoxib and gefitinib.
- timeFrame
- 1 year
Secondary outcomes (2)
- measure
- To evaluate the safety profile of celecoxib and ZD1839.
- timeFrame
- 30 days
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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. -
References
Publications (0)
Data not yet available
No reference posted for this study.