Head and Neck Cancer Clinical Trial
Official title:
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.
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
;
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
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