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A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839
This study is currently recruiting participants.
Verified by National University Hospital, Singapore, July 2008
Sponsors and Collaborators: National University Hospital, Singapore
National Healthcare Group, Singapore
Information provided by: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00212108
  Purpose

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.


Condition Intervention Phase
Nasopharyngeal Carcinoma
Drug: celecoxib, gefitinib
Phase I
Phase II

MedlinePlus related topics: Cancer
Drug Information available for: ZD1839 Celecoxib 4-(5-(4-Methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl)benzenesulfonamide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title: A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839

Further study details as provided by National University Hospital, Singapore:

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.

Estimated Enrollment: 20
Study Start Date: November 2003
Estimated Study Completion Date: August 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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. -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00212108

Contacts
Contact: Ross Soo, MD 65 67795555 soolk@nuh.com.sg

Locations
Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: Ross Soo, MD     65 67795555     soolk@nuh.com.sg    
Principal Investigator: Ross Soo, MD            
Sub-Investigator: Goh Boon Cher, MD            
Sub-Investigator: Thomas Loh, MD            
Sponsors and Collaborators
National University Hospital, Singapore
National Healthcare Group, Singapore
Investigators
Principal Investigator: Ross Soo, MD National University Hospital, Singapore
  More Information

Responsible Party: National University Hospital, Singapore ( Ross Soo, MD )
Study ID Numbers: NP01/07/03
Study First Received: September 13, 2005
Last Updated: July 10, 2008
ClinicalTrials.gov Identifier: NCT00212108  
Health Authority: Singapore: Health Sciences Authority;   Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
celecoxib, NPC, gefitinib

Study placed in the following topic categories:
Celecoxib
Nasopharyngeal carcinoma
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Pharyngeal Neoplasms
Stomatognathic Diseases
Gefitinib
Pharyngeal Diseases
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Nasopharyngeal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009