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

Sponsor:	Northwestern University
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00058006

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 II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Lung Cancer

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by Northwestern University:

Study Start Date:	September 2002
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00058006

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

Sponsors and Collaborators

Northwestern University

National Cancer Institute (NCI)

Investigators

Study Chair:

Athanassios Argiris, MD

Robert H. Lurie Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bharat Mittal, MD, 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:	February 18, 2011
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 February 12, 2012