A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839
|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.|
|ClinicalTrials.gov Identifier: NCT00212108|
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : April 2, 2012
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 or disease||Intervention/treatment||Phase|
|Nasopharyngeal Carcinoma||Drug: celecoxib, gefitinib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839|
|Study Start Date :||November 2003|
|Actual Primary Completion Date :||March 2007|
|Actual Study Completion Date :||January 2009|
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™)
- To study histopathological changes in tumor following inhibition with celecoxib and gefitinib. [ Time Frame: 1 year ]
- 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 ]
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
|National University Hospital|
|Singapore, Singapore, 119074|
|Principal Investigator:||Ross Soo, MD||National University Hospital, Singapore|