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A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839
This study is currently recruiting participants.
Study NCT00212108   Information provided by National University Hospital, Singapore
First Received: September 13, 2005   Last Updated: July 10, 2008   History of Changes

September 13, 2005
July 10, 2008
November 2003
 
To study histopathological changes in tumor following inhibition with celecoxib and gefitinib.
Same as current
Complete list of historical versions of study NCT00212108 on ClinicalTrials.gov Archive Site
  • To evaluate the safety profile of celecoxib and ZD1839.
  • To assess the pharmacokinetics of ZD1839 and celecoxib.
Same as current
 
A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839
A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839

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.

 
Phase I, Phase II
Interventional
Allocation:  Non-Randomized
Control:  Uncontrolled
Endpoint Classification:  Pharmacokinetics/Dynamics Study
Intervention Model:  Single Group Assignment
Masking:  Open Label
Primary Purpose:  Treatment
Nasopharyngeal Carcinoma
Drug: celecoxib, gefitinib
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
20
August 2005
 

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. -
Both
18 Years and older
No
Contact: Ross Soo, MD 65 67795555 soolk@nuh.com.sg
Singapore
 
NCT00212108
Ross Soo, MD, National University Hospital, Singapore
NP01/07/03
National University Hospital, Singapore
National Healthcare Group, Singapore
Principal Investigator: Ross Soo, MD National University Hospital, Singapore
National University Hospital, Singapore
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP