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

National University Health System (NUHS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: celecoxib, gefitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT00212108

NP01/07/03

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Celecoxib and ZD1839

Experimental group

Description:

Celecoxib and ZD1839 will be given twice a day and daily respectively for two consecutive weeks prior to further anti-cancer treatment.

Treatment:

Drug: celecoxib, gefitinib