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

This study has been completed.
Sponsor:
Collaborator:
National Healthcare Group, Singapore
Information provided by (Responsible Party):
Haematology-Oncology, National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00212108
First received: September 13, 2005
Last updated: March 29, 2012
Last verified: March 2012
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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 National University Hospital, Singapore:

Primary Outcome Measures:
  • To study histopathological changes in tumor following inhibition with celecoxib and gefitinib. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety profile of celecoxib and ZD1839. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • To assess the pharmacokinetics of ZD1839 and celecoxib. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 13, 2005
Last Updated: March 29, 2012
Health Authority: Singapore: Health Sciences Authority
Singapore: Domain Specific Review Boards

Keywords provided by 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
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 30, 2014