Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI, Pharmaceutical / Industry NU-02V2 PHARMACIA-NU-02V2, NCT00058006

Objectives

1. 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.
2. Compare the event-free and overall survival of patients treated with this drug vs placebo.
3. Determine the toxic effects associated with long-term use of celecoxib in these patients.
4. 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.

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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Platelet count at least 50,000/mm³

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

Expected Enrollment

A total of 121 patients (approximately 60 per treatment arm) will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Athanassios Argiris, MD, Protocol chair(Contact information may not be current)		Ph: 312-695-4441

Registry Information
Official Title		Pilot Randomized Trial Of Adjuvant Celecoxib In Patients With Early Stage Head And Neck And Non-Small Cell Lung Cancers
Trial Start Date		2002-09-12
Trial Completion Date		2005-04-12
Registered in ClinicalTrials.gov		NCT00058006
Date Submitted to PDQ		2003-02-10
Information Last Verified		2005-05-06
NCI Grant/Contract Number		CA60553

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