NCT00357617

Celecoxib in Treating Patients With Head and Neck Cancer That Can Be Removed By Surgery

Evaluation of the Effect of Celecoxib on Angiogenesis Markers in Patients With Operable Head and Neck Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Centre Hospitalier Universitaire Vaudois · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-06-01
• First posted: 2006-07-27
• Last updated: 2010-12-24

Locations

1 site across 1 country: Switzerland