Lung CancerPhase 2NCT00020878
Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers
A Phase 2 study testing celecoxib in people with Lung Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Celecoxib may be effective in preventing lung cancer in tobacco smokers. PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing non-small cell lung cancer in tobacco smokers. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2001to May 2009
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 45
- Smoked > 20 pack years
Who cannot join
- Concurrent use of NSAIDs
- Hypersensitivity to celecoxib
- Documented allergic-type reaction to sulfonamides
- History of allergic reaction, urticaria or asthma to aspirin or other NSAIDs
- History of liver dysfunction
- Hypertension or cardiac conditions aggravated by fluid retention and edema
Show all 14Show fewer
- Previous history of gastrointestinal ulceration, bleeding, or perforation
- Renal dysfunction
- End stage respiratory disease
- Unstable angina
- Other malignancy
- Pregnancy
- Concurrent use of medication known to alter or be affected by alteration of the hepatic p450 2C9 and 2D6 enzymes
- Patents with concurrent medical conditions that may interfere with completion of tests, therapy, or the follow up schedule
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
About this study
Official title: Celecoxib for Chemoprevention of Primary Lung Cancer
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Celecoxib may be effective in preventing lung cancer in tobacco smokers.
PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing non-small cell lung cancer in tobacco smokers.
Read the detailed description
OBJECTIVES:
- Determine the efficacy and feasibility of celecoxib for chemoprevention of primary non-small cell lung cancer in high-risk tobacco smokers.
- Determine the safety and long-term side effects of this drug in this population.
OUTLINE: Patients receive oral celecoxib twice daily for 6 months.
Patients are followed at 2 weeks and then at 6 months.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 6 months.
- Conditions
- Lung Cancer
- Being tested
- celecoxib
- Keywords
- non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
celecoxibDrug
Also called Celebrex
Dosing will occur for a total of 6 months. 400 mg by mouth twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | See intervention description. Receives: Drug: celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the expression of Cox-2 and PGE2 in the lungs of tobacco smokers.
Measured: 1 year
Evaluate the capacity for an oral Cox-2 inhibitor (Celecoxib) to suppress the intrapulmonary formation of PGE2
Measured: 1 year
Secondary outcomes (2)
Determine the effects of Cox-2 inhibition on biomarkers of field cancerization on histopathologic abnormalities in patients at risk for primary NSCLC
Measured: 2 years
Study the potential role of PGE2 and its regulation by Cox-2 specific inhibitors on antitumor immunity within the lung microenvironment
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startMar 2001
- Primary completionNov 2002
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jenny T. Mao, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00020878
- Sponsor's protocol ID
- CDR0000068727
- Other IDs
- UCLA-0012067, NCI-G01-1966
- Status last verified
- Mar 2016
- First submitted
- 11 Jul 2001
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Celecoxib for Chemoprevention of Primary Lung Cancer
- ClinicalTrials.gov ID
- NCT00020878
- Acronym / sponsor ID
- CDR0000068727
- Conditions
- Lung Cancer
- Keywords
- non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Mar 2001
- Primary completion
- Nov 2002 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 27 Jan 2003 (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. Celecoxib may be effective in preventing lung cancer in tobacco smokers.
PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing non-small cell lung cancer in tobacco smokers.
Detailed description
OBJECTIVES:
- Determine the efficacy and feasibility of celecoxib for chemoprevention of primary non-small cell lung cancer in high-risk tobacco smokers.
- Determine the safety and long-term side effects of this drug in this population.
OUTLINE: Patients receive oral celecoxib twice daily for 6 months.
Patients are followed at 2 weeks and then at 6 months.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Drug: celecoxibSee intervention description. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 45
- Smoked > 20 pack years
Key exclusion criteria (14 listed)
- Concurrent use of NSAIDs
- Hypersensitivity to celecoxib
- Documented allergic-type reaction to sulfonamides
- History of allergic reaction, urticaria or asthma to aspirin or other NSAIDs
- History of liver dysfunction
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 |
|---|---|---|
| celecoxibAlso: CelebrexDosing will occur for a total of 6 months. 400 mg by mouth twice daily. | Drug | Study |
Primary outcome
Evaluate the expression of Cox-2 and PGE2 in the lungs of tobacco smokers.
Time frame: 1 year
Evaluate the capacity for an oral Cox-2 inhibitor (Celecoxib) to suppress the intrapulmonary formation of PGE2
Time frame: 1 year
2 secondary outcomes
Determine the effects of Cox-2 inhibition on biomarkers of field cancerization on histopathologic abnormalities in patients at risk for primary NSCLC
Time frame: 2 years
Study the potential role of PGE2 and its regulation by Cox-2 specific inhibitors on antitumor immunity within the lung microenvironment
Time frame: 2 years
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 3 Aug 2020.
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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.
Jenny T. Mao, MD principal investigator
Jonsson Comprehensive 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 Lung Cancer, run by Jonsson Comprehensive 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?
The sponsor lists 2 inclusion and 14 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 3 Aug 2020. 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.
What does the primary outcome measure?
Evaluate the expression of Cox-2 and PGE2 in the lungs of tobacco smokers. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 3 Aug 2020.