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Sponsored by: |
Centre Hospitalier Universitaire Vaudois |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00357617 |
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 | Intervention | Phase |
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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 I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled |
Official Title: | Evaluation of the Effect of Celecoxib on Angiogenesis Markers in Patients With Operable Head and Neck Squamous Cell Carcinoma |
Estimated Enrollment: | 24 |
Study Start Date: | June 2006 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed or high clinical suspicion of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx
Clinical stage T1-4, N0-2, M0 disease
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No concurrent administration of any of the following:
Aspirin
Switzerland | |
Centre Hospitalier Universitaire Vaudois | Recruiting |
Lausanne, Switzerland, CH-1011 | |
Contact: Francois Luthi, MD 41-213-140-155 |
Study Chair: | Francois Luthi, MD | Centre Hospitalier Universitaire Vaudois |
Study ID Numbers: | CDR0000490047, CHUV-CEPO-161-05, EU-20627 |
Study First Received: | July 26, 2006 |
Last Updated: | February 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00357617 History of Changes |
Health Authority: | Unspecified |
stage I squamous cell carcinoma of the hypopharynx stage II squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the hypopharynx stage IV squamous cell carcinoma of the hypopharynx stage I squamous cell carcinoma of the larynx stage II squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage I squamous cell carcinoma of the lip and oral cavity stage II squamous cell carcinoma of the lip and oral cavity |
stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage I squamous cell carcinoma of the oropharynx stage II squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the hypopharynx recurrent squamous cell carcinoma of the larynx recurrent squamous cell carcinoma of the lip and oral cavity recurrent squamous cell carcinoma of the oropharynx |
Anti-Inflammatory Agents Celecoxib Laryngeal Carcinoma Cyclooxygenase Inhibitors Squamous Cell Carcinoma Recurrence Carcinoma Hypopharyngeal Cancer Analgesics, Non-Narcotic |
Head and Neck Neoplasms Epidermoid Carcinoma Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Neoplasms, Squamous Cell Antirheumatic Agents Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |
Anti-Inflammatory Agents Neoplasms by Histologic Type Celecoxib Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Carcinoma Neoplasms Neoplasms by Site Sensory System Agents |
Analgesics, Non-Narcotic Therapeutic Uses Head and Neck Neoplasms Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Neoplasms, Squamous Cell Antirheumatic Agents Carcinoma, Squamous Cell Central Nervous System Agents Neoplasms, Glandular and Epithelial |