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: Randomized phase II trial to study the effectiveness of celecoxib in preventing disease recurrence in patients who have stage I or stage II head and neck cancer or stage I non-small cell lung cancer.

Condition	Treatment or Intervention	Phase
Head and Neck Cancer thorax and respiratory cancer	Drug: celecoxib  Procedure: adjuvant therapy  Procedure: anti-cytokine therapy  Procedure: antiangiogenesis therapy  Procedure: biological response modifier therapy  Procedure: enzyme inhibitor therapy  Procedure: growth factor antagonist therapy	Phase II

Further Study Details: 

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.

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

Criteria

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

Illinois
      Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago,  Illinois,  60611-3013,  United States
      Rush Cancer Institute at Rush University Medical Center, Chicago,  Illinois,  60612,  United States
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637-1470,  United States
North Carolina
      Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill,  North Carolina,  27599-7295,  United States

Study chairs or principal investigators

Athanassios Argiris, MD,  Study Chair,  Robert H. Lurie Cancer Center   

Study ID Numbers:  CDR0000285671; NU-02V2; PHARMACIA-NU-02V2; NCT00058006
Record last reviewed:  February 2005
Last Updated:  February 17, 2005
Record first received:  April 7, 2003
ClinicalTrials.gov Identifier:  NCT00058006
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08