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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00212108
• Other study ID #: NP01/07/03
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 13, 2005
• Last updated: March 29, 2012
• Start date: November 2003
• Est. completion date: January 2009

Study information

• Verified date: March 2012
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences AuthoritySingapore: Domain Specific Review Boards
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2009
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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. -

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Drug:
• celecoxib, 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.

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	National Healthcare Group, Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To study histopathological changes in tumor following inhibition with celecoxib and gefitinib.		1 year	No
Secondary	To evaluate the safety profile of celecoxib and ZD1839.		30 days	Yes
Secondary	To assess the pharmacokinetics of ZD1839 and celecoxib.		30 days	No