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

Information source: National University Hospital, Singapore
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nasopharyngeal Carcinoma

Intervention: celecoxib, gefitinib (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: National University Hospital, Singapore

Official(s) and/or principal investigator(s):
Ross Soo, MD, Principal Investigator, Affiliation: National University Hospital, Singapore

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: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

National University Hospital, Singapore 119074, Singapore
Additional Information

Starting date: November 2003
Last updated: March 29, 2012

Page last updated: August 23, 2015

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