Lung Cancer Clinical Trial
Official title:
Pilot Randomized Trial Of Adjuvant Celecoxib In Patients With Early Stage Head And Neck And Non-Small Cell Lung Cancers
Verified date | June 2012 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 0 |
Est. completion date | December 2006 |
Est. primary completion date | December 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina |
United States | Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois |
United States | Rush Cancer Institute at Rush University Medical Center | Chicago | Illinois |
United States | University of Chicago Cancer Research Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Northwestern University | National Cancer Institute (NCI) |
United States,
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