Head and Neck CancerPhase 2NCT00014404
Celecoxib in Treating Patients With Precancerous Lesions of the Mouth
A Phase 2 study testing celecoxib in people with Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 3 sites in United States.
Trial summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of celecoxib may be an effective way to prevent the further development of precancerous lesions in the mouth. 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
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Oct 2000to Jan 2006
- 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: Histologically confirmed index oral premalignant lesion(s) 8 mm or greater in size Not biopsied within the past 6 weeks Early premalignant lesion with atypical cells or mild dysplasia OR Advanced premalignant lesion with moderate or severe dysplasia
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Zubrod 0-1 Life expectancy: More than 12 weeks Hematopoietic: Hemoglobin greater than lower limit of normal WBC greater than 3,000/mm3 Platelet count greater than 125,000/mm3 No significant bleeding disorder Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST/ALT no greater than 1.5 times ULN No chronic or acute hepatic disorder Renal: BUN no greater than 1.5 times ULN Creatinine no greater than 1.5 times ULN No chronic or acute renal disorder Gastrointestinal: No diagnosis or treatment of esophageal, gastric, pyloric channel, or duodenal ulceration within past 30 days No prior or active pancreatic disease or inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis) Other: Completed a smoking cessation program, if applicable No prior hypersensitivity to COX-2 inhibitors, NSAIDs, salicylates, or sulfonamides No prior invasive cancer within the past 5 years except non-melanoma skin cancer or carcinoma in situ of the cervix No other concurrent condition that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior immunotherapy and recovered No concurrent immunotherapy Chemotherapy: At least 3 weeks since prior chemotherapy and recovered No concurrent chemotherapy Endocrine therapy: At least 3 weeks since prior hormonal therapy (except hormone replacement therapy for menopause) and recovered No concurrent hormonal therapy except hormone replacement therapy for menopause Less than 14 days of oral or IV corticosteroid use within the past 6 months Less than 30 days of inhaled corticosteroid use within the past 6 months Radiotherapy: At least 3 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: See Disease Characteristics Other: No prior participation in and withdrawal from this study At least 3 months since any other prior chemopreventive therapy and recovered At least 30 days since prior investigational agents At least 2 weeks since prior beta-carotene at 60 mg/day or more No concurrent beta-carotene at 60 mg/day or more No concurrent oral aspirin greater than 100 mg/day No other concurrent investigational agents No concurrent fluconazole or lithium No concurrent chronic NSAIDs or COX-2 inhibitors
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
Weill Medical College of Cornell University
New York, New York, 10021
About this study
Official title: Phase II Double-Blind, Placebo Controlled, Randomized Study Of Celecoxib, A Selective COX-2 Inhibitor, In Oral Premalignant Lesions
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of celecoxib may be an effective way to prevent the further development of precancerous lesions in the mouth.
PURPOSE: Randomized phase II trial to compare the effectiveness of different regimens of celecoxib in treating patients who have precancerous lesions in the mouth.
Read the detailed description
OBJECTIVES: I. Determine the efficacy of celecoxib, in terms of clinical response and histological response, in patients with oral premalignant lesions. II. Evaluate the safety of chronic multiple dosing of celecoxib in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to premalignant risk (early vs advanced). Patients in each stratum are randomized to 1 of 3 treatments arms. Arm I: Patients receive lower-dose oral celecoxib twice daily. Arm II: Patients receive higher-dose oral celecoxib twice daily. Arm III: Patients receive oral placebo twice daily. Treatment continues in all 3 arms for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 18, 24, and 26 weeks.
PROJECTED ACCRUAL: A total of 84 patients (42 per stratum, 14 per arm) will be accrued for this study within 6 months.
- Conditions
- Head and Neck Cancer
- Being tested
- celecoxib
- Keywords
- lip and oral cavity cancer
- Medical subject headings
- Head and Neck Neoplasms, Mouth Neoplasms
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 posted7 Jan 2004 (estimated)
- Study startOct 2000
- Primary completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Jay O. Boyle, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00014404
- Sponsor's protocol ID
- 00-111
- Other IDs
- MSKCC-00111, NCI-G01-1930
- Status last verified
- Jan 2013
- First submitted
- 10 Apr 2001
- Last updated
- 16 Jan 2013
- Results posted
- No
Publications
Papadimitrakopoulou VA, William WN Jr, Dannenberg AJ, Lippman SM, Lee JJ, Ondrey FG, Peterson DE, Feng L, Atwell A, El-Naggar AK, Nathan CO, Helman JI, Du B, Yueh B, Boyle JO. Pilot randomized phase II study of celecoxib in oral premalignant lesions. Clin Cancer Res. 2008 Apr 1;14(7):2095-101. doi: 10.1158/1078-0432.CCR-07-4024.
PubMed 18381950
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Double-Blind, Placebo Controlled, Randomized Study Of Celecoxib, A Selective COX-2 Inhibitor, In Oral Premalignant Lesions
- ClinicalTrials.gov ID
- NCT00014404
- Acronym / sponsor ID
- 00-111
- Conditions
- Head and Neck Cancer
- Keywords
- lip and oral cavity cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2000
- Primary completion
- Jan 2006 (actual)
- First posted
- 7 Jan 2004 (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 therapy is the use of certain drugs to try to prevent the development of cancer. The use of celecoxib may be an effective way to prevent the further development of precancerous lesions in the mouth.
PURPOSE: Randomized phase II trial to compare the effectiveness of different regimens of celecoxib in treating patients who have precancerous lesions in the mouth.
Detailed description
OBJECTIVES: I. Determine the efficacy of celecoxib, in terms of clinical response and histological response, in patients with oral premalignant lesions. II. Evaluate the safety of chronic multiple dosing of celecoxib in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to premalignant risk (early vs advanced). Patients in each stratum are randomized to 1 of 3 treatments arms. Arm I: Patients receive lower-dose oral celecoxib twice daily. Arm II: Patients receive higher-dose oral celecoxib twice daily. Arm III: Patients receive oral placebo twice daily. Treatment continues in all 3 arms for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed at 18, 24, and 26 weeks.
PROJECTED ACCRUAL: A total of 84 patients (42 per stratum, 14 per arm) will be accrued for this study within 6 months.
Study design
- Primary purpose
- Prevention
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 16 Jan 2013.
- Results publication: PubMed 18381950Papadimitrakopoulou VA, William WN Jr, Dannenberg AJ, Lippman SM, Lee JJ, Ondrey FG, Peterson DE, Feng L, Atwell A, El-Naggar AK, Nathan CO, Helman JI, Du B, Yueh B, Boyle JO. Pilot randomized phase II study of celecoxib in oral premalignant lesions. Clin Cancer Res. 2008 Apr 1;14(7):2095-101. doi: 10.1158/1078-0432.CCR-07-4024.
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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.
Jay O. Boyle, MD study chair
Memorial Sloan Kettering Cancer Center
3 sites 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, run by Memorial Sloan Kettering Cancer Center 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?
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 16 Jan 2013. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00014404, which also lists 1 linked publication.
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 16 Jan 2013.