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Home > "C" Clinical Trials Conditions > Celecoxib in Treating Patients With Early-Stage Head and Neck Cancer or Non-Small Cell Lung Cancer  Celecoxib in Treating Patients With Early-Stage Head and Neck Cancer or Non-Small Cell Lung Cancer
Celecoxib in Treating Patients With Early-Stage Head and Neck Cancer or Non-Small Cell Lung Cancer
For Condition: Head and Neck Cancer,thorax and respiratory cancer
Status: Recruiting
Sponsor(s): Robert H. Lurie Cancer Center , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase 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.
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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AthanassiosArgiris, Study Chair, Robert H. Lurie Cancer Center
Evanston Northwestern Health Care - Evanston Hospital *Recruiting*
Evanston, Illinois, 60201-1781
United States
Recruiting Bruce Brockstein 847-570-1489
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611-3013
United States
Recruiting Athanassios Argiris 312-695-4441
Additional Information:
Study ID Numbers: CDR0000285671; NU-02V2,PHARMACIA-NU-02V2
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00058006
Other Thorax And Respiratory Cancer Studies:
1. Docetaxel and St. John's Wort in Treating Patients With Solid Tumors That Cannot Be Removed By Surgery
2. Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer, Ovarian Cancer, or Head and Neck Cancer
3. Docetaxel in Treating Patients With Solid Tumors
4. Gefitinib in Treating Patients With Metastatic or Unresectable Head and Neck Cancer or Non-Small Cell Lung Cancer
5. Alanosine in Treating Patients With Cancer
Related Studies:
Other thorax and respiratory cancer Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Celecoxib in Treating Patients With Early-Stage Head and Neck Cancer or Non-Small Cell Lung Cancer
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