Celecoxib in Treating Patients With Head and Neck Cancer That Can Be Removed By Surgery
Recruitment status was Active, not recruiting
|First Received Date ICMJE||July 26, 2006|
|Last Updated Date||December 23, 2010|
|Start Date ICMJE||June 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Molecular markers of angiogenesis in tumor tissues (PGE2, VEGF, MMP-9, sFlt-1, ERK phosphorylation, PKB phosphorylation, and ErbB2 levels) [ Designated as safety issue: No ]|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00357617 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Celecoxib in Treating Patients With Head and Neck Cancer That Can Be Removed By Surgery|
|Official Title ICMJE||Evaluation of the Effect of Celecoxib on Angiogenesis Markers in Patients With Operable Head and Neck Squamous Cell Carcinoma|
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving celecoxib before surgery may reduce the amount of normal tissue that needs to be removed. Collecting and storing samples of tumor tissue, blood, and urine from patients with head and neck cancer to study in the laboratory may help doctors learn more about the cancer and predict how well patients will respond to treatment with celecoxib.
PURPOSE: This phase I/II trial is studying changes in tumor cells and how well celecoxib works in treating patients with head and neck cancer that can be removed by surgery.
OUTLINE: This is an open-label, nonrandomized, uncontrolled study.
Patients undergo panendoscopy and tumor biopsy on day 0. Patients receive oral celecoxib twice daily beginning on day 1 and continuing for at least 14 days*. Patients then undergo definitive surgery.
NOTE: *Treatment continues until the day before surgery.
Tumor, blood, and urine samples are collected at baseline and periodically during study. Tumor quantification by perfusion CT scan is performed at baseline and after treatment with celecoxib. Biological markers are detected by immunohistochemistry and enzyme immunoassay. Blood vascular density, apoptosis, proliferation, and endothelial cell:tumor ratio are measured by indirect hemagglutination. Gene expression is measured by microarray analysis.
After surgery, patients are followed at 4 weeks and then periodically thereafter.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 1
|Study Design ICMJE||Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
|Condition ICMJE||Head and Neck Cancer|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||24|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
PRIOR CONCURRENT THERAPY:
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Switzerland|
|NCT Number ICMJE||NCT00357617|
|Other Study ID Numbers ICMJE||CDR0000490047, CHUV-CEPO-161-05, EU-20627|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Centre Hospitalier Universitaire Vaudois|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Cancer Institute (NCI)|
|Verification Date||January 2008|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP