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

Primary Purpose

Nasopharyngeal Carcinoma

Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
celecoxib, gefitinib
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring celecoxib, NPC, gefitinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Histologically proven NPC. Any clinical stage NPC as defined by the AJCC/UICC System. No prior radiotherapy, chemoradiotherapy, immunotherapy or investigational agents. No prior NSAIDs or corticosteroids for at least 4 weeks. ECOG performance status ≤ 2. Adequate end organ function Life expectancy > 3 months. Signed informed consent - Exclusion Criteria: Inability to take celecoxib and gefitinib for the specified period of time (14 days) prior to definitive therapy. Tumor not visible on fibre nasopharyngoscopy for biopsy. Known peptic ulcer disease. Evidence of clinically active interstitial lung disease. 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. 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. Women of childbearing potential who are not practising adequate contraception. Concurrent medical problems that would significantly limit compliance with the study. 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. 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. Known HIV, HBV or HCV infection. -

Sites / Locations

  • National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Celecoxib and ZD1839

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To evaluate the safety profile of celecoxib and ZD1839.
To assess the pharmacokinetics of ZD1839 and celecoxib.

Full Information

First Posted
September 13, 2005
Last Updated
March 29, 2012
Sponsor
National University Hospital, Singapore
Collaborators
National Healthcare Group, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT00212108
Brief Title
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

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University Hospital, Singapore
Collaborators
National Healthcare Group, Singapore

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
celecoxib, NPC, gefitinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Celecoxib and ZD1839
Arm Type
Experimental
Arm Description
Celecoxib and ZD1839 will be given twice a day and daily respectively for two consecutive weeks prior to further anti-cancer treatment.
Intervention Type
Drug
Intervention Name(s)
celecoxib, gefitinib
Other Intervention Name(s)
ZD1839 (Iressa™)
Intervention Description
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.
Primary Outcome Measure Information:
Title
To study histopathological changes in tumor following inhibition with celecoxib and gefitinib.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To evaluate the safety profile of celecoxib and ZD1839.
Time Frame
30 days
Title
To assess the pharmacokinetics of ZD1839 and celecoxib.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically proven NPC. Any clinical stage NPC as defined by the AJCC/UICC System. No prior radiotherapy, chemoradiotherapy, immunotherapy or investigational agents. No prior NSAIDs or corticosteroids for at least 4 weeks. ECOG performance status ≤ 2. Adequate end organ function Life expectancy > 3 months. Signed informed consent - Exclusion Criteria: Inability to take celecoxib and gefitinib for the specified period of time (14 days) prior to definitive therapy. Tumor not visible on fibre nasopharyngoscopy for biopsy. Known peptic ulcer disease. Evidence of clinically active interstitial lung disease. 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. 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. Women of childbearing potential who are not practising adequate contraception. Concurrent medical problems that would significantly limit compliance with the study. 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. 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. Known HIV, HBV or HCV infection. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ross Soo, MD
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore

12. IPD Sharing Statement

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

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