Lung CancerPhase 2NCT00055978
Celecoxib in Preventing Lung Cancer in Former Heavy Smokers
A Phase 2 study testing celecoxib in people with Lung Cancer, run by University of California, Los Angeles at 1 site in United States.
Trial summary
RATIONALE: Chemoprevention therapy uses certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing the development or recurrence of lung cancer in former heavy 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?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to 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
- Heavy former smokers without prior history of NSCLC
- Age > 45
- Smoked for minimum of 30 pack years
- Former smokers with prior curative resection of surgical stage I NSCLC will be recruited and must be:
- Age > 18
- Smoked > 10 pack years
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- Must have had pathological staging and the extent of disease documented. At least one nodal station each must have been biopsied and all biopsies must have been negative
- At least 6 months post curative resection of Stage I prior NSCLC, without evidence for recurrence or second primary lung cancer
- Normal blood chemistry and cell counts
- Negative pregnancy test
Who cannot join
- Framingham 10-year-risk for coronary artery disease score > 10%
- History of cardiovascular disease
- Evidence of diffuse coronary calcification on screening CT
- Concurrent use of NSAIDs. The use of cardiac (baby) Aspirin is permitted
- Hypersensitivity to celecoxib, sulfonamides, aspirin or other NSAIDs
- Liver dysfunction [abnormally elevated liver function tests [transaminases (ALT, AST) > ULN, alkaline phosphatase (ALKP) > 1.5 ULN]] or history of cirrhosis
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- No peptic ulcer disease (PUD) diagnosis nor active symptoms in the last 2 years or, if PUD was diagnosed < 2 years, there must be no active symptoms, and endoscopic confirmation of healing
- Renal dysfunction [abnormally elevated blood urea nitrogen (BUN) > 1.5 ULN and creatinine > ULN]
- End state respiratory disease
- Unstable angina or a history of significant coronary artery disease
- Other malignancies excluding non-melanoma type skin cancer and in situ cervical cancer. Persons with stage I/II head and neck cancer must be disease free for at least 12 months
- Pregnancy
- Lactation
- Unwillingness to practice contraception
- On systemic corticoid steroid therapy
- Coagulopathy
- Use of Coumadin
- Concurrent use of medication know to alter or be affected by alteration of hepatic p450 2C9 enzymes.
- Patients with concurrent medical conditions that may interfere with completion of tests, therapy, or the follow up schedule
- Patients who had received photosensitizing agents such as hematoporphyrin derivative or chemopreventive drugs such as retinoids within 3 months prior to the bronchoscopic procedure, radiotherapy to the chest, or cytotoxic chemotherapy agents
- Subject found to have CIS during screening bronchoscopy will be treated with local therapy prior to randomization
Trial locations and contacts
1 site in 1 country.
United States1 site
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, 90095-1781
About this study
Official title: Lung Cancer Chemoprevention With Celecoxib In Ex-Smokers
RATIONALE: Chemoprevention therapy uses certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing the development or recurrence of lung cancer in former heavy smokers.
PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing the development or recurrence of lung cancer in former heavy smokers who are at risk of developing cancer.
Read the detailed description
OBJECTIVES:
- Determine the feasibility of chemoprevention of lung cancer with celecoxib in former heavy smokers at risk for developing primary or second primary lung cancer.
- Determine the safety and side effects of this drug in these patients.
- Determine the quality of life of patients treated with this drug.
- Determine the role of COX-2-specific inhibitors (e.g., celecoxib) on antitumor immunity within the lung microenvironment of these patients.
- Determine the effects of COX-2 inhibition on angiogenesis in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to presence of preinvasive lesions (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral placebo twice daily for 6 months.
- Arm II: Patients receive oral celecoxib twice daily for 6 months. Treatment in both arms continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed every 6 months during treatment and then annually for up to 4 years.
Patients are followed annually for up to 4 years.
PROJECTED ACCRUAL: A total of 180 patients (90 per treatment arm) will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- celecoxib, placebo
- Keywords
- non-small cell lung cancer, stage I 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, Celebra
Given orally. 400mg twice daily for 6 months.
placeboOther
Given orally
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive oral placebo twice daily for 6 months. Receives: Other: placebo |
| Arm II | Experimental | Patients receive oral celecoxib twice daily for 6 months. Receives: Drug: celecoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modulation of the ki-67 labeling index
Measured: 5 years
Phenotypic modulation of the bronchial histology
Measured: 5 years
Secondary outcomes (3)
Evidence of molecular/genetic aberrations
Measured: 5 years
Changes indicative of response to treatment in the targeted signaling pathway
Measured: 5 years
Parameters that reflect the overall balance of the epigenetic phenomenon thought to facilitate or promote tumorigenesis
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2003 (estimated)
- Study startOct 2002
- Primary completionMar 2008
- 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 University of California, Los AngelesThe 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
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Jenny T. Mao, MD, Principal investigator, Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00055978
- Sponsor's protocol ID
- CDR0000271912
- Other IDs
- U01CA096134, P30CA016042, UCLA-0108074
- Status last verified
- Jun 2011
- First submitted
- 6 Mar 2003
- Last updated
- 20 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Cancer Chemoprevention With Celecoxib In Ex-Smokers
- ClinicalTrials.gov ID
- NCT00055978
- Acronym / sponsor ID
- CDR0000271912
- Conditions
- Lung Cancer
- Keywords
- non-small cell lung cancer, stage I non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2002
- Primary completion
- Mar 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 7 Mar 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 uses certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing the development or recurrence of lung cancer in former heavy smokers.
PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing the development or recurrence of lung cancer in former heavy smokers who are at risk of developing cancer.
Detailed description
OBJECTIVES:
- Determine the feasibility of chemoprevention of lung cancer with celecoxib in former heavy smokers at risk for developing primary or second primary lung cancer.
- Determine the safety and side effects of this drug in these patients.
- Determine the quality of life of patients treated with this drug.
- Determine the role of COX-2-specific inhibitors (e.g., celecoxib) on antitumor immunity within the lung microenvironment of these patients.
- Determine the effects of COX-2 inhibition on angiogenesis in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to presence of preinvasive lesions (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral placebo twice daily for 6 months.
- Arm II: Patients receive oral celecoxib twice daily for 6 months. Treatment in both arms continues in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed every 6 months during treatment and then annually for up to 4 years.
Patients are followed annually for up to 4 years.
PROJECTED ACCRUAL: A total of 180 patients (90 per treatment arm) will be accrued for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Other: placeboPatients receive oral placebo twice daily for 6 months. |
| Arm II | Experimental | Drug: celecoxibPatients receive oral celecoxib twice daily for 6 months. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Heavy former smokers without prior history of NSCLC
- Former smokers with prior curative resection of surgical stage I NSCLC will be recruited and must be:
- Normal blood chemistry and cell counts
- Negative pregnancy test
Key exclusion criteria (21 listed)
- Framingham 10-year-risk for coronary artery disease score > 10%
- History of cardiovascular disease
- Evidence of diffuse coronary calcification on screening CT
- Concurrent use of NSAIDs. The use of cardiac (baby) Aspirin is permitted
- Hypersensitivity to celecoxib, sulfonamides, aspirin or other NSAIDs
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: Celebrex, CelebraGiven orally. 400mg twice daily for 6 months. | Drug | Arm II |
| placeboGiven orally | Other | Arm I |
Primary outcome
Modulation of the ki-67 labeling index
Time frame: 5 years
Phenotypic modulation of the bronchial histology
Time frame: 5 years
3 secondary outcomes
Evidence of molecular/genetic aberrations
Time frame: 5 years
Changes indicative of response to treatment in the targeted signaling pathway
Time frame: 5 years
Parameters that reflect the overall balance of the epigenetic phenomenon thought to facilitate or promote tumorigenesis
Time frame: 5 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 20 Jun 2011.
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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 University of California, Los Angeles 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 10 inclusion and 21 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 20 Jun 2011. 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?
Modulation of the ki-67 labeling index (time frame: 5 years). 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 20 Jun 2011.