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	Treatment or Intervention	Phase
Non-small cell lung cancer stage I non-small cell lung cancer	Drug: celecoxib  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Procedure: biological response modifier therapy  Procedure: cancer prevention intervention  Procedure: chemoprevention of cancer  Procedure: growth factor antagonist therapy	Phase II

Further Study 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). 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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Former heavy smoker meeting the following high-risk criteria for lung cancer:
• 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 10 pack years
• Quit smoking at least 1 year ago

PATIENT CHARACTERISTICS: Age

• 18 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)

California
      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States; Recruiting

Study chairs or principal investigators

Jenny T. Mao, MD,  Study Chair,  Jonsson Comprehensive Cancer Center   

Study ID Numbers:  CDR0000271912; UCLA-0108074; NCT00055978
Record last reviewed:  April 2004
Last Updated:  December 6, 2004
Record first received:  March 6, 2003
ClinicalTrials.gov Identifier:  NCT00055978
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08