Celecoxib in Treating Patients With Early-Stage Head and Neck Cancer or Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be an effective way to prevent the recurrence of stage I or stage II head and neck cancer or stage I non-small cell lung cancer. PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works compared to that of a placebo in preventing disease recurrence in patients with stage I or stage II head and neck cancer or stage I non-small cell lung cancer.

Detailed Description
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OBJECTIVES: Compare the rate of new malignancies (recurrences and second primary tumors) in patients with early-stage head and neck cancer or non-small cell lung cancer treated with celecoxib vs placebo. Compare the event-free and overall survival of patients treated with this drug vs placebo. Determine the toxic effects associated with long-term use of celecoxib in these patients. Correlate cyclooxygenase-2 and transforming growth factor (TGF)-beta expression and CYP2C9 and TGF-beta genotypes with the rate of new malignancies and survival of patients treated with this drug vs placebo. OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to smoking history (active smokers [including those who quit within 1 year of diagnosis] vs former smokers vs non-smokers), tumor type (lung cancer vs head and neck cancer), and stage (I vs II for head and neck cancer or T1 vs T2 for lung cancer). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive oral celecoxib twice daily. Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for 24 months in the absence of disease recurrence or unacceptable toxicity. Patients are followed every 6 months for 5 years or until disease recurrence. PROJECTED ACCRUAL: A total of 121 patients (approximately 60 per treatment arm) will be accrued for this study.

Official Title
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Pilot Randomized Trial Of Adjuvant Celecoxib In Patients With Early Stage Head And Neck And Non-Small Cell Lung Cancers

Conditions
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Head and Neck Cancer, Lung Cancer

Intervention / Treatment
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* Drug: celecoxib
* Procedure: adjuvant therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: One of the following histologically confirmed diagnoses: Stage I non-small cell lung cancer (NSCLC) No small cell component Stage I-II squamous cell cancer of the head and neck No WHO type II or III nasopharyngeal cancer No sinonasal undifferentiated carcinoma No evidence of disease Must have undergone surgery or radiotherapy with curative intent within the past 4-24 weeks PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-1 Life expectancy Not specified Hematopoietic Platelet count at least 50,000/mm^3 Hepatic Bilirubin normal AST/ALT no greater than 2 times upper limit of normal Renal Creatinine no greater than 2.0 mg/dL Cardiovascular No uncontrolled hypertension No severe congestive heart failure Pulmonary No history of asthma caused by cyclooxygenase-2 (COX-2) inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, or sulfonamides Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study participation No other prior malignancy (including skin cancer and in situ malignancies) No diagnosis of peptic ulcer disease or gastritis/esophagitis within the past 60 days No prior hypersensitivity reaction to COX-2 inhibitors, NSAIDs, salicylates, or sulfonamides No other concurrent medical condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy No cumulative oral or IV corticosteroid use totalling more than 2 weeks within the past 3 months No concurrent oral steroids for more than 2 consecutive weeks Concurrent inhaled steroids allowed Radiotherapy See Disease Characteristics No prior definitive radiotherapy for stage I NSCLC Surgery See Disease Characteristics Prior pneumonectomy or lobectomy with mediastinal lymph node sampling or dissection for stage I NSCLC allowed No prior segmentectomies or wedge resections for stage I NSCLC Other More than 60 days since prior treatment for peptic ulcer disease or gastritis/esophagitis No prior NSAID use within the past 30 days at a frequency of 3 or more times a week for more than 2 weeks No concurrent NSAIDs (including low-dose aspirin) No other concurrent COX-2 inhibitors No concurrent fluconazole No concurrent lithium

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: celecoxib|nan|
|Procedure: adjuvant therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I non-small cell lung cancer, stage I squamous cell carcinoma of the hypopharynx, stage I squamous cell carcinoma of the larynx, stage I squamous cell carcinoma of the lip and oral cavity, stage I squamous cell carcinoma of the nasopharynx, stage I squamous cell carcinoma of the oropharynx, stage I squamous cell carcinoma of the paranasal sinus and nasal cavity, stage II squamous cell carcinoma of the hypopharynx, stage II squamous cell carcinoma of the larynx, stage II squamous cell carcinoma of the lip and oral cavity, stage II squamous cell carcinoma of the nasopharynx, stage II squamous cell carcinoma of the oropharynx, stage II squamous cell carcinoma of the paranasal sinus and nasal cavity, salivary gland squamous cell carcinoma, stage I salivary gland cancer, stage II salivary gland cancer