Celecoxib in Preventing Lung Cancer in Former Heavy Smokers
This study has been completed.
Sponsor:
University of California, Los Angeles
Collaborator:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00055978
First received: March 6, 2003
Last updated: June 16, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Drug: celecoxib Other: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | Lung Cancer Chemoprevention With Celecoxib In Ex-Smokers |
Resource links provided by NLM:
Further study details as provided by University of California, Los Angeles:
Primary Outcome Measures:
- Modulation of the ki-67 labeling index [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Phenotypic modulation of the bronchial histology [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evidence of molecular/genetic aberrations [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Changes indicative of response to treatment in the targeted signaling pathway [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Parameters that reflect the overall balance of the epigenetic phenomenon thought to facilitate or promote tumorigenesis [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Enrollment: | 112 |
| Study Start Date: | October 2002 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I
Patients receive oral placebo twice daily for 6 months.
|
Other: placebo
Given orally
|
|
Experimental: Arm II
Patients receive oral celecoxib twice daily for 6 months.
|
Drug: celecoxib
Given orally. 400mg twice daily for 6 months.
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 45 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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
- 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
Exclusion Criteria:
- 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00055978
Locations
| United States, California | |
| Jonsson Comprehensive Cancer Center at UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
Sponsors and Collaborators
University of California, Los Angeles
Investigators
| Principal Investigator: | Jenny T. Mao, MD | Jonsson Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jenny T. Mao, Jonsson Comprehensive Cancer Center at UCLA |
| ClinicalTrials.gov Identifier: | NCT00055978 History of Changes |
| Other Study ID Numbers: | CDR0000271912, U01CA096134, P30CA016042, UCLA-0108074 |
| Study First Received: | March 6, 2003 |
| Last Updated: | June 16, 2011 |
| Health Authority: | United States: Federal Government United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by University of California, Los Angeles:
|
non-small cell lung cancer stage I non-small cell lung cancer |
Additional relevant MeSH terms:
|
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Celecoxib Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 21, 2013