Head and Neck CancerPhase 2NCT00101335
Celecoxib in Preventing Head and Neck Cancer in Patients With Oral Leukoplakia
A Phase 2 study testing celecoxib in people with Head and Neck Cancer and Precancerous Condition, run by Fox Chase Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of celecoxib may prevent or treat head and neck cancer. PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works compared to placebo in preventing head and neck cancer in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Precancerous Condition
- What is being tested?
- celecoxib
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Nov 2003to Jan 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
DISEASE CHARACTERISTICS:
- Diagnosis of oral leukoplakia with hyperplasia or dysplasia
- Documented by baseline biopsy of oral lesions suspicious for leukoplakia
- For patients using dentures over the past 6 months, only lesions located on the ventral-lateral tongue or floor of the mouth are allowed
- No leukoplakia/hyperplasia secondary to mechanical irritation
- No carcinoma in situ of the oral cavity
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Not specified
Life expectancy
- At least 1 year
Hematopoietic
- Hemoglobin ≥ 10 g/dL (women) OR ≥ 11 g/dL (men)
Hepatic
- AST or ALT normal
- Bilirubin normal
Renal
- Creatinine normal OR
- Creatinine clearance ≥ 60 mL/min
Cardiovascular
- No myocardial infarction within the past 12 months
- No known active ischemic cardiac disease by stress test or echocardiogram
Gastrointestinal
- No history of gastrointestinal hemorrhage
- No known gastrointestinal ulcers within the past 2 years unless there is documentation of healed lesions by upper endoscopy
- No active or suspected peptic ulcer disease
- Negative stool guaiac test
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study treatment
- No use of snuff or chewing tobacco within the past 2 months
- No active invasive malignancy within the past 3 years except nonmelanoma skin cancer or in situ carcinomas
- No clinical evidence of chronic infectious disease
- No clinical evidence of connective tissue disease
- No known hypersensitivity (asthma, urticaria, or acute rhinitis induced by NSAIDs) to aspirin or other NSAIDs
- No known hypersensitivity to sulfonamides
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- At least 6 months since prior chronic or frequent use of systemic glucocorticoids
- No concurrent chronic or frequent use of systemic glucocorticoids
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- No prior chronic or frequent (> 100 mg per day aspirin equivalent) use of nonsteroidal anti-inflammatory drugs (NSAIDs) for 7 of the past 14 days
- At least 3 months since prior experimental therapy
- No concurrent chronic or frequent use of NSAIDs
- Cardioprotective doses of aspirin ≤ 100 mg daily are allowed
Trial locations and contacts
1 site in 1 country.
United States1 site
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111-2497
About this study
Official title: A Phase IIb Cancer Prevention Trial of Celecoxib, a Selective COX-2 Inhibitor, in Oral Leukoplakia
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of celecoxib may prevent or treat head and neck cancer.
PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works compared to placebo in preventing head and neck cancer in patients with oral leukoplakia.
Read the detailed description
OBJECTIVES:
Primary
- Compare the clinical efficacy of celecoxib vs placebo, in terms of inducing regression of oral leukoplakia lesions, in patients with hyperplastic or dysplastic oral leukoplakia.
Secondary
- Determine the effect of this drug in modulating multiple intermediate biomarkers (e.g., COX-2, PPARγ, or PPARδ) in normal and hyperplastic or dysplastic oral epithelia of these patients.
- Determine the safety of this drug in these patients.
- Determine the cost-effectiveness of this drug as a chemopreventative agent in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, cross-over study. Patients are stratified according to the pathology of the leukoplakia lesion (dysplasia vs hyperplasia). Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive oral celecoxib twice daily for 3 months.
- Arm II: Patients receive oral placebo twice daily for 3 months. All patients undergo biopsy. Patients then cross-over to the opposite treatment arm for 3 months.
In both arms, treatment continues in the absence of unacceptable toxicity or disease progression.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 27-60 patients (18-40 for study drug, 9-20 for placebo before cross-over) will be accrued for this study.
- Conditions
- Head and Neck Cancer, Precancerous Condition
- Being tested
- celecoxib
- Keywords
- hypopharyngeal cancer, lip and oral cavity cancer, nasopharyngeal cancer, oropharyngeal cancer, tongue cancer, oral leukoplakia
- Medical subject headings
- Head and Neck Neoplasms, Precancerous Conditions, Hypopharyngeal Neoplasms, Mouth Neoplasms, Nasopharyngeal Neoplasms, Oropharyngeal Neoplasms, Tongue Neoplasms, Leukoplakia, Oral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxibDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2005 (estimated)
- Study startNov 2003
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Fox Chase Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Fox Chase Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Paul F. Engstrom, MD, Principal investigator, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00101335
- Sponsor's protocol ID
- FCCC-02028
- Other IDs
- CDR0000393574
- Status last verified
- Jul 2013
- First submitted
- 7 Jan 2005
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIb Cancer Prevention Trial of Celecoxib, a Selective COX-2 Inhibitor, in Oral Leukoplakia
- ClinicalTrials.gov ID
- NCT00101335
- Acronym / sponsor ID
- FCCC-02028
- Conditions
- Head and Neck Cancer, Precancerous Condition
- Keywords
- hypopharyngeal cancer, lip and oral cavity cancer, nasopharyngeal cancer, oropharyngeal cancer, tongue cancer, oral leukoplakia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Fox Chase Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2003
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 10 Jan 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of celecoxib may prevent or treat head and neck cancer.
PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works compared to placebo in preventing head and neck cancer in patients with oral leukoplakia.
Detailed description
OBJECTIVES:
Primary
- Compare the clinical efficacy of celecoxib vs placebo, in terms of inducing regression of oral leukoplakia lesions, in patients with hyperplastic or dysplastic oral leukoplakia.
Secondary
- Determine the effect of this drug in modulating multiple intermediate biomarkers (e.g., COX-2, PPARγ, or PPARδ) in normal and hyperplastic or dysplastic oral epithelia of these patients.
- Determine the safety of this drug in these patients.
- Determine the cost-effectiveness of this drug as a chemopreventative agent in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, cross-over study. Patients are stratified according to the pathology of the leukoplakia lesion (dysplasia vs hyperplasia). Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive oral celecoxib twice daily for 3 months.
- Arm II: Patients receive oral placebo twice daily for 3 months. All patients undergo biopsy. Patients then cross-over to the opposite treatment arm for 3 months.
In both arms, treatment continues in the absence of unacceptable toxicity or disease progression.
Patients are followed at 1 month.
PROJECTED ACCRUAL: A total of 27-60 patients (18-40 for study drug, 9-20 for placebo before cross-over) will be accrued for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| celecoxib | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul F. Engstrom, MD principal investigator
Fox Chase Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing celecoxib in people with Head and Neck Cancer and Precancerous Condition, run by Fox Chase Cancer Center at 1 site 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?
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 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Where can I read the original study information?
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 11 Jul 2013.