Celecoxib in Treating Patients With Early-Stage Head and Neck Cancer or Non-Small Cell Lung Cancer
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Cancer Lung Cancer |
Drug: celecoxib Procedure: adjuvant therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Pilot Randomized Trial Of Adjuvant Celecoxib In Patients With Early Stage Head And Neck And Non-Small Cell Lung Cancers |
| Study Start Date: | September 2002 |
| Study Completion Date: | December 2006 |
| Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Illinois | |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | |
| Chicago, Illinois, United States, 60611-3013 | |
| Rush Cancer Institute at Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637-1470 | |
| United States, North Carolina | |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599-7295 | |
| Study Chair: | Athanassios Argiris, MD | Robert H. Lurie Cancer Center |
More Information
No publications provided
| Responsible Party: | Northwestern University |
| ClinicalTrials.gov Identifier: | NCT00058006 History of Changes |
| Other Study ID Numbers: | NU 02V2, NU-02V2, PHARMACIA-NU-02V2 |
| Study First Received: | April 7, 2003 |
| Last Updated: | June 7, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Northwestern University:
|
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 |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Head and Neck Neoplasms Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Adjuvants, Immunologic Celecoxib Immunologic Factors Physiological Effects of Drugs |
Pharmacologic Actions Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 19, 2013