Clinical trial NCT00212108: A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839
Official title: A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Nasopharyngeal Carcinoma
Keywords: celecoxib, NPC, gefitinib
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: National Healthcare Group, Singapore
First posted: 2005-09-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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. -

Primary outcomes:
measure: To study histopathological changes in tumor following inhibition with celecoxib and gefitinib.
timeFrame: 1 year
Secondary outcomes:
measure: To evaluate the safety profile of celecoxib and ZD1839.
timeFrame: 30 days
measure: To assess the pharmacokinetics of ZD1839 and celecoxib.
timeFrame: 30 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Ross Soo, MD
role: PRINCIPAL_INVESTIGATOR
References: