Celecoxib in Treating Patients With Early-Stage Head and Neck Cancer or Non-Small Cell Lung Cancer

NCT00058006 | Completed Phase 2

• 3 other identifiers: NU 02V2NU-02V2PHARMACIA-NU-02V2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

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.

Conditions

Head and Neck Cancer; Lung Cancer

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

Interventions

celecoxib DRUG

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

Rush Cancer Institute at Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago Cancer Research Center

Chicago, Illinois, 60637-1470, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Squamous Cell Carcinoma of Head and Neck; Salivary Gland Neoplasms

Interventions

Celecoxib; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Athanassios Argiris, MD

  Robert H. Lurie Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2003
• First Posted: April 9, 2003
• Study Start: September 1, 2002
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: June 11, 2012

Record last verified: 2012-06

Locations

US (4)