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Home > "C" Clinical Trials Conditions > Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers  Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers
Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers
For Condition: Non-small cell lung cancer
Status: No longer recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 45 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Smoked more than 20 pack years - Evidence of airflow obstruction (FEV_1 less than 80%) - No end-stage respiratory disease (e.g., FEV_1 less than 0.8 liters, or resting or exertional hypoxemia) PATIENT CHARACTERISTICS: Age: - Over 45 Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - No history of liver dysfunction Renal: - No renal dysfunction Cardiovascular: - No hypertension - No cardiac condition aggravated by fluid retention and edema - No unstable angina Pulmonary: - See Disease Characteristics Other: - Not pregnant - Negative pregnancy test - Fertile patients must use effective contraception during and for 7 days after study participation - No malignancy - No hypersensitivity to celecoxib - No allergic reaction to sulfonamides - No prior allergic reaction (urticaria or asthma) to aspirin or other NSAIDs - No prior gastrointestinal ulceration, bleeding, or perforation - No concurrent medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Not specified Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified Other: - No concurrent non-steroidal anti-inflammatory drugs (NSAIDs) - No concurrent medication known to alter or be affected by alteration of the hepatic p450 2C9 and 2D6 enzymes (e.g., rifampin, fluconazole, fluvastatin, zafirlukast, sulfaphenazole, cimetidine, fluoxetine, paroxetine, quinidine, amiodarone, or ritonavir)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JennyMao, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Additional Information:
Study ID Numbers: CDR0000068727; UCLA-0012067,NCI-G01-1966
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00020878
Other Non-Small Cell Lung Cancer Studies:
1. Gefitinib in Treating Patients With Non-Small Cell Lung Cancer That Has Been Surgically Removed
2. Selenium in Preventing Tumor Growth in Patients With Previously Resected Stage I Non-small Cell Lung Cancer
3. Evaluation of efficacy, safety and tolerability of Targretin capsules in patients with advanced or metastatic non-small cell lung cancer
4. Oral Investigational Drug Vs. Approved Intravenous Treatment In Pretreated, Advanced Non-Small Cell Lung Cancer (NSCLC).
5. Docetaxel With or Without Exisulind in Treating Patients With Non-Small Cell Lung Cancer
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Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers
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