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Head and Neck CancerPhase 2NCT00052611

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

A Phase 2 study testing Celecoxib in people with Head and Neck Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
Celecoxib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
3 sitesUnited States
Study dates
Jun 2002to Mar 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

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

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Celecoxib In Biomarker Modulation Of Oral Precancerous Lesions: A Pilot Study

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.

Read the detailed description

Celecoxib is being studied in precancerous lesions of the head and neck in part because, it has been shown to prevent the progression of another type of precancerous polyps (a type of abnormal growth) in patients at high risk for colorectal cancer. There are, however, no published studies yet looking at this drug in humans for the prevention of head and neck cancers. The U.S. Food and Drug Administration has approved celecoxib for arthritis and the prevention of polyps in patients with familial adenomatous polyposis (a type of precancerous syndrome in some families that can lead to colon cancer).

This study is being done to find out several things:

  • Is celecoxib, also known by the trade name Celebrex ®, effective in reducing the expression of precancerous markers (biological signals for specific cellular activities) in oral leukoplakia and dysplasia (abnormal growth) of the oral mucosa?
  • Is celecoxib effective in reducing the size of oral leukoplalda lesions and/or presence of dysplasia?
  • Does the reduction in precancerous markers correspond with reduction of oral leukoplalda and/or presence of dysplasia?
  • What are the side effects of celecoxib in this patient population?
Being tested
Celecoxib
Keywords
lip and oral cavity cancer, paranasal sinus and nasal cavity cancer, hypopharyngeal cancer, laryngeal cancer, oropharyngeal cancer, nasopharyngeal cancer, salivary gland cancer
Medical subject headings
Head and Neck Neoplasms, Mouth Neoplasms, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Oropharyngeal Neoplasms, Nasopharyngeal Neoplasms, Salivary Gland Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00052611
Study groupRoleWhat they receive
CelecoxibExperimentalCelecoxib 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.
Receives: Drug: Celecoxib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Rate Of PGE2

    Measured: 2 years

Secondary outcomes (9)

  1. Change In SEB Expression Of COX-2

    Measured: 2 years

  2. Response Of Measurable Lesions

    Measured: 2 years

  3. Assessing Safety

    Measured: 2 years

  4. Change In SEB Expression Of Akt

    Measured: 2 years

  5. Change In SEB Expression Of Ki-67

    Measured: 2 years

  6. Change In SEB Expression Of BCL2

    Measured: 2 years

  7. Change In SEB Expression Of BAX

    Measured: 2 years

  8. Change In SEB Expression Of VEGF

    Measured: 2 years

  9. Change In SEB Expression Of CD31

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJun 2002
  3. Primary completionMar 2005
  4. Study completionMar 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00052611
Sponsor's protocol ID
02-024
Other IDs
P30CA006516, DFCI-02024, DFCI-2002-P-00150/2
Status last verified
Mar 2018
First submitted
24 Jan 2003
Last updated
29 Mar 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Celecoxib in people with Head and Neck Cancer, run by Dana-Farber Cancer Institute at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate Of PGE2 (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00052611.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2018.

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