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| Sponsor: | Dana-Farber Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00052611 |
Purpose
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing head and neck cancer in patients who have oral leukoplakia or head and neck dysplasia.
PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing cancer in patients who have oral leukoplakia and/or head and neck dysplasia.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer |
Drug: celecoxib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Celecoxib In Biomarker Modulation Of Oral Precancerous Lesions: A Pilot Study |
| Study Start Date: | June 2002 |
OBJECTIVES:
OUTLINE: This is an open-label, multicenter study.
Patients receive oral celecoxib twice daily for 3 months. After 3 months, patients undergo a repeat biopsy. Patients with a positive response receive celecoxib for an additional 9 months.
Patients are followed every 3-6 months for 1 year.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 30 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
No concurrent tobacco use (e.g., cigarette, cigar, pipe, or chewing tobacco)
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
More than 3 months since prior absorbed steroids, including inhaled and nasal steroids (3 times a week for at least 2 consecutive weeks)
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Massachusetts General Hospital Cancer Center | |
| Boston, Massachusetts, United States, 02114 | |
| Study Chair: | Lori J. Wirth, MD | Dana-Farber Cancer Institute |
More Information
| ClinicalTrials.gov Identifier: | NCT00052611 History of Changes |
| Other Study ID Numbers: | CDR0000258562, DFCI-02024, DFCI-2002-P-00150/2 |
| Study First Received: | January 24, 2003 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
|
lip and oral cavity cancer paranasal sinus and nasal cavity cancer hypopharyngeal cancer laryngeal cancer |
oropharyngeal cancer nasopharyngeal cancer salivary gland cancer |
|
Head and Neck Neoplasms Leukoplakia, Oral Neoplasms by Site Neoplasms Mouth Neoplasms Leukoplakia Precancerous Conditions Mouth Diseases Stomatognathic Diseases Pathological Conditions, Anatomical Celecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |