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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00212108
First Posted: September 21, 2005
Last Update Posted: April 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Healthcare Group, Singapore
Information provided by (Responsible Party):
Haematology-Oncology, National University Hospital, Singapore
  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 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839

Resource links provided by NLM:


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

Primary Outcome Measures:
  • To study histopathological changes in tumor following inhibition with celecoxib and gefitinib. [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • To evaluate the safety profile of celecoxib and ZD1839. [ Time Frame: 30 days ]
  • To assess the pharmacokinetics of ZD1839 and celecoxib. [ Time Frame: 30 days ]

Enrollment: 22
Study Start Date: November 2003
Study Completion Date: January 2009
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Celecoxib and ZD1839
Celecoxib and ZD1839 will be given twice a day and daily respectively for two consecutive weeks prior to further anti-cancer treatment.
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.
Other Name: ZD1839 (Iressa™)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00212108


Locations
Singapore
National University Hospital
Singapore, Singapore, 119074
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: Haematology-Oncology, Dr. Ross Soo, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00212108     History of Changes
Other Study ID Numbers: NP01/07/03
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: April 2, 2012
Last Verified: March 2012

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

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases
Celecoxib
Gefitinib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Protein Kinase Inhibitors