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Home > "C" Clinical Trials Conditions > Celecoxib in Preventing Lung Cancer in Former Heavy Smokers  Celecoxib in Preventing Lung Cancer in Former Heavy Smokers
Celecoxib in Preventing Lung Cancer in Former Heavy Smokers
For Condition: Non-small cell lung cancer,Small Cell Lung Cancer,stage 1 non-small cell lung cancer
Status: Recruiting
Sponsor(s): Jonsson Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase 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.
Details: 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) and prior history of stage I NSCLC (yes vs no). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive oral placebo twice daily for 6 months followed by oral celecoxib twice daily for 6 months. - Arm II: Patients receive oral celecoxib twice daily for 6 months followed by oral placebo 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 4 years. Patients are followed annually for 4 years. PROJECTED ACCRUAL: A total of 180 patients (90 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Former heavy smoker meeting one of the following high-risk criteria for lung cancer: - Evidence of airflow obstruction - Histologically confirmed stage I non-small cell lung cancer (NSCLC) that was curatively treated at least 6 months ago, with no evidence of recurrence or second primary tumor - Smoked for at least 30 pack years (at least 10 pack years for patients with resected NSCLC) - Quit smoking at least 1 year ago PATIENT CHARACTERISTICS: Age - 45 and over (former smokers) - 18 and over (resected NSCLC patients) Performance status - Not specified Life expectancy - Not specified Hematopoietic - Blood chemistry and cell counts normal Hepatic - No history of cirrhosis - No liver dysfunction - ALT/AST normal - Alkaline phosphatase normal - Lactic dehydrogenase normal - No coagulopathy Renal - No renal dysfunction - BUN normal - Creatinine normal Cardiovascular - No history of significant coronary artery disease - No unstable angina Pulmonary - FEV_1 and FVC no greater than 70% of predicted (not required for patients with prior NSCLC) - No end-stage respiratory disease Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No prior gastrointestinal ulceration, bleeding, or perforation - No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No known hypersensitivity to celecoxib, sulfonamides, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs) - No other concurrent medical condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior cytotoxic chemotherapy Endocrine therapy - No concurrent systemic corticosteroids Radiotherapy - No prior radiotherapy to the chest Surgery - See Disease Characteristics Other - More than 3 months since prior chemopreventive drugs (e.g., retinoids) - More than 3 weeks since prior NSAIDs - More than 3 months since prior photosensitizing agents (e.g., hematoporphyrin derivative) - No concurrent NSAIDs (except baby aspirin) - No concurrent warfarin - No concurrent medications known to alter or be affected by the alteration of hepatic enzyme p450 2C9 (e.g., fluconazole)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JennyMao, Study Chair, Jonsson Comprehensive Cancer Center
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1781
United States
Recruiting Jenny Mao 310-825-3100
Additional Information:
Study ID Numbers: CDR0000271912; UCLA-0108074
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055978
Other Small Cell Lung Cancer Studies:
1. Phase III Randomized Study of Nicotine Inhaler Versus Bupropion Versus Nicotine Inhaler Plus Bupropion for Smoking Cessation and Prevention of Relapse in Participants Who Currently Smoke
2. Diflomotecan (BN80915) Administered Once Every 3 Weeks in Treating Patients with Sensitive Small Cell Lung Cancer (SCLC)
3. INS316 Compared With Saline for Sputum Collection in Diagnosing Lung Cancer
4. Inhaled Doxorubicin in Treating Patients With Primary Lung Cancer or Lung Metastases
5. Isotretinoin With or Without Vitamin E for Prevention of Lung Cancer
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Celecoxib in Preventing Lung Cancer in Former Heavy Smokers
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