Head and Neck Cancer, Lung Cancer
Conditions
Keywords
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
Brief summary
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
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.
Interventions
DRUGcelecoxib
PROCEDUREadjuvant therapy
Sponsors
National Cancer Institute (NCI)
Northwestern University
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed