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| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | July 10, 2008 | ||||
| Start Date ICMJE | November 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
To study histopathological changes in tumor following inhibition with celecoxib and gefitinib. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00212108 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839 | ||||
| Official Title ICMJE | A Study Of Nasopharyngeal Carcinoma (NPC) Treated With Celecoxib And ZD1839 | ||||
| Brief 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. |
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| Detailed Description | |||||
| Study Phase | Phase I, Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Allocation: Non-Randomized Control: Uncontrolled Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Nasopharyngeal Carcinoma | ||||
| Intervention ICMJE | Drug: celecoxib, gefitinib | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | August 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Singapore | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00212108 | ||||
| Responsible Party | Ross Soo, MD, National University Hospital, Singapore | ||||
| Study ID Numbers ICMJE | NP01/07/03 | ||||
| Study Sponsor ICMJE | National University Hospital, Singapore | ||||
| Collaborators ICMJE | National Healthcare Group, Singapore | ||||
| Investigators ICMJE |
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| Information Provided By | National University Hospital, Singapore | ||||
| Verification Date | July 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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