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Clinical Trial Name - Celecoxib in Preventing Lung Cancer in Former Heavy Smokers
| Original Study ID : CDR0000271912 |
| Secondary ID : UCLA-0108074 |
| NCT ID : NCT00055978 |
| Brief Title : Celecoxib in Preventing Lung Cancer in Former Heavy Smokers |
| Official Title : Lung Cancer Chemoprevention With Celecoxib In Ex-Smokers |
| Brief 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. 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. |
| Source : National Cancer Institute (NCI) |
| 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 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 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. |
| Overall Status : Active, not recruiting |
| Start Date : October 2002 |
| Official Title : Phase 2 |
| Phase : Interventional |
| Study Design : Prevention, Randomized, Double-Blind, Placebo Control |
| Enrollment : 180 |
| Verification Date : February 2009 |
| First Received Date : March 6, 2003 |
| Trial Eligibility |
| Criteria : DISEASE CHARACTERISTICS: - Former heavy smoker meeting 1 of the following high-risk criteria for lung cancer: - 30 pack years - 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, and smoked for at least 10 pack years - Quit smoking at least 1 year ago PATIENT CHARACTERISTICS: Age - 45 and over 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 - 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) |
| Gender : Both |
| Minimum Age : 45 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : Jonsson Comprehensive Cancer Center at UCLA |
| City : Los Angeles |
| State : California |
| Zip Code : 90095-1781 |
| Country : United States |
| OutComes |
| Primary OutComes |
| Secondary OutComes |
| Measure : Evidence of molecular/genetic aberrations |
| Safety issue : No |
| Measure : Changes indicative of response to treatment in the targeted signaling pathway |
| Safety issue : No |
| Measure : Parameters that reflect the overall balance of the epigenetic phenomenon thought to facilitate or promote tumorigenesis |
| Safety issue : No |
| Interventions |
| Type : Drug |
| Name : celecoxib |
| Description : Given orally |
| Type : Other |
| Name : placebo |
| Description : Given orally |
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