A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839
Information source: National University Hospital, Singapore
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nasopharyngeal Carcinoma
Intervention: celecoxib, gefitinib (Drug)
Phase: Phase 1/Phase 2
Status: Recruiting
Sponsored by: National University Hospital, Singapore Official(s) and/or principal investigator(s):
Ross Soo, MD, Principal Investigator, Affiliation: National University Hospital, Singapore
Overall contact:
Ross Soo, MD, Phone: 65 67795555, Email: soolk@nuh.com.sg
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.
Clinical Details
Official title: A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: To study histopathological changes in tumor following inhibition with celecoxib and gefitinib.
Secondary outcome: To evaluate the safety profile of celecoxib and ZD1839.To assess the pharmacokinetics of ZD1839 and celecoxib.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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. -
Locations and Contacts
Ross Soo, MD, Phone: 65 67795555, Email: soolk@nuh.com.sg
National University Hospital, Singapore 119074, Singapore; Recruiting
Ross Soo, MD, Phone: 65 67795555, Email: soolk@nuh.com.sg
Ross Soo, MD, Principal Investigator
Goh Boon Cher, MD, Sub-Investigator
Thomas Loh, MD, Sub-Investigator
Additional Information
Starting date: November 2003
Ending date: August 2005
Last updated: July 10, 2008
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