Celecoxib in Treating Patients With Head and Neck Cancer That Can Be Removed By Surgery
|ClinicalTrials.gov Identifier: NCT00357617|
Recruitment Status : Unknown
Verified January 2008 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : July 27, 2006
Last Update Posted : December 24, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: celecoxib Genetic: microarray analysis Genetic: protein expression analysis Other: immunoenzyme technique Other: immunohistochemistry staining method Other: laboratory biomarker analysis Procedure: biopsy Procedure: conventional surgery Procedure: neoadjuvant therapy||Phase 1 Phase 2|
- Evaluate the changes in molecular markers of angiogenesis before and after treatment with celecoxib in tumor tissues of patients with resectable head and neck squamous cell carcinoma.
- Evaluate the changes in molecular markers of angiogenesis before and after treatment with celecoxib in blood tissues of these patients.
- Evaluate the effects of celecoxib on indirect measures of tumor perfusion, as measured by perfusion CT scan, in these patients.
- Evaluate the effects of celecoxib on apoptosis and proliferation rate on tumor cells and on endothelial cells in these patients.
- Identify potential new markers of the activity of cyclooxygenase-2 inhibitors and identify new pathways of potential interests by performing gene expression profiling of tumor tissues before and after exposure to celecoxib.
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Effect of Celecoxib on Angiogenesis Markers in Patients With Operable Head and Neck Squamous Cell Carcinoma|
|Study Start Date :||June 2006|
U.S. FDA Resources
- Molecular markers of angiogenesis in tumor tissues (PGE2, VEGF, MMP-9, sFlt-1, ERK phosphorylation, PKB phosphorylation, and ErbB2 levels)
- Molecular markers in plasma (VEGF, MMP-9, and sFlt1)
- Molecular marker in urine (PGE2)
- Apoptosis/proliferation in tumor cells and endothelial cells
- Gene expression profiling in fresh tumor tissues (Erb-B2, c-IAP-2, PAI-1, MAPK-4, integrin α V, N-CAM, caspase 6, ErbB2 transducer, angiopoietin like-2, interleukin-8, and MMP13)
- Tumor perfusion imaging by perfusion CT scan
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00357617
|Centre Hospitalier Universitaire Vaudois|
|Lausanne, Switzerland, CH-1011|
|Study Chair:||Francois Luthi, MD||Centre Hospitalier Universitaire Vaudois|