Celecoxib in Preventing Cancer in Patients With Oral Leukoplakia and/or Head and Neck Dysplasia

NCT00052611 | Completed Phase 2 DMC FDA Drug

• 4 other identifiers: 02-024P30CA006516DFCI-02024DFCI-2002-P-00150/2
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

Brief Summary

Patient at increased risk for developing a new head and neck squamous cell carcinoma are invited to take part in this study. The investigators of this trial will attempt to study the effectiveness of Celecoxib in preventing cancer in patients who have oral leukoplakia and/or head and neck dysplasia.

Conditions

Head and Neck Cancer

Keywords

lip and oral cavity cancer; paranasal sinus and nasal cavity cancer; hypopharyngeal cancer; laryngeal cancer; oropharyngeal cancer; nasopharyngeal cancer; salivary gland cancer

Outcome Measures

Primary Outcomes (1)

• Response Rate Of PGE2

  2 years

Secondary Outcomes (9)

• Change In SEB Expression Of COX-2

  2 years

• Response Of Measurable Lesions

  2 years

• Assessing Safety

  2 years

• Change In SEB Expression Of Akt

  2 years

• Change In SEB Expression Of Ki-67

  2 years

Study Arms (1)

Celecoxib

EXPERIMENTAL

Celecoxib will be given at a pre-determine dose twice daily for 3 months. If there is a favorable change in biomarker expression on biopsy at 3 months, treatment will continue to complete a 12-month treatment period.

Drug: Celecoxib

Interventions

Celecoxib DRUG

Also known as: Celebrex

Celecoxib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be ≥ 18 years.
• Subjects will have oral leukoplakia on clinical examination and/or more than one previous HNSCC with dysplasia histologically proven on random biopsy within 6 months at the time of entry.
• Patients who have had surgical treatment for a previous HNSCC, stage I-III, will be eligible for enrollment if they are cancer-free ≥ 9 months at the time of entry. Patients with CIS or new leukoplakia will be immediately eligible if they are more then 9 months from treatment of a prior carcinoma.
• Leukoplakia lesions must be ≥ 0.5 cm in at least one dimension to be considered measurable. Measurable lesions are not required for entry.
• The ECOG performance status will be ≤ 2. (See Appendix B for ECOG performance status.)
• The life expectancy will be ≥12 months.
• Subjects will have adequate organ function with a platelet count of \>100,000, ANC \> 1500, PT and PTT \< 1.5 X ULN, creatinine \<1.5, urine protein \<2+, and total bilirubin and liver transaminases \<1.5 X ULN.
• Premenopausal women will be required to use a reliable method of birth control throughout the course of therapy.
• Subjects will provide written, voluntary informed consent

You may not qualify if:

• Patients who have had surgical treatment for a previous HNSCC, stage I-III, will not be eligible for enrollment if they are cancer-free \< 9 months at the time of entry.
• Subjects with contraindication to nasopharyngoscopy and biopsy will not be enrolled.
• Significant comorbidities, including known coronary artery disease, angina, history of myocardial infarction, congestive heart failure of at least grade 2 according to the New York Heart Association Criteria, advanced COPD requiring use of home oxygen, active alcohol abuse, bleeding diathesis, any history of gastrointestinal ulcer, acute or chronic renal insufficiency, or acute or chronic liver disease, will preclude enrollment in the trial.
• Enrollment in the trial will be limited to patients who are free from current tobacco use. If the patient has a history of previous tobacco use, they Must be abstinent for at least 1 month prior to enrollment and meet the criteria established by the Food and Drug Administration for assessing smoking cessation, i.e. have not taken even a puff or taste of tobacco, including cigarette, cigar, pipe, chewing tobacco or other tobacco products, in the past 4 weeks.
• Any active malignancy, except non-melanoma skin cancer, will preclude enrollment.
• Persons who have taken full-dose aspirin, NSAIDs, COX-2 inhibitors and systemicallyabsorbed steroids, including inhaled steroids and nasal steroids other than mometazone, at least 3 times per week for 2 or more consecutive weeks within 3 months of enrollment will be excluded. Persons who have taken retinoids or selenium within 3 months of enrollment, or who have a history of anaphylactoid reaction to aspirin, NSAIDs or COX- 2 inhibitors will not be enrolled.
• Persons taking ACE inhibitors will not be enrolled. Diuretics for CHF, or treatment with lithium or fluconazole will also preclude enrollment. Patients on coumadin will be required to have PT/INR monitoring BIW after starting celecoxib, until the patient is on a stable dose of coumadin for 7 days, and must have no contraindication to holding the coumadin for study biopsies.
• Pregnant, lactating women or premenopausal women with a positive f3HCG will not be enrolled in the study.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Mouth Neoplasms; Hypopharyngeal Neoplasms; Laryngeal Neoplasms; Oropharyngeal Neoplasms; Nasopharyngeal Neoplasms; Salivary Gland Neoplasms

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Nasopharyngeal Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Lori J. Wirth, MD

  Dana-Farber Cancer Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Wirth, Lori MD

Study Record Dates

• First Submitted: January 24, 2003
• First Posted: January 27, 2003
• Study Start: June 1, 2002
• Primary Completion: March 1, 2005
• Study Completion: March 1, 2005
• Last Updated: March 29, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)