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

Alternate Title

Celecoxib in Preventing Lung Cancer in Former Heavy Smokers

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Prevention Active 45 and over NCI UCLA-0108074 NCT00055978

Objectives

1. Determine the feasibility of chemoprevention of lung cancer with celecoxib in former heavy smokers at risk for developing primary or second primary lung cancer.
2. Determine the safety and side effects of this drug in these patients.
3. Determine the quality of life of patients treated with this drug.
4. Determine the role of COX-2-specific inhibitors (e.g., celecoxib) on antitumor immunity within the lung microenvironment of these patients.
5. Determine the effects of COX-2 inhibition on angiogenesis in these patients.

Entry Criteria

Disease Characteristics:

• Former heavy smoker meeting 1 of the following high-risk criteria for lung cancer:
  • 30 pack years
  • Histologically confirmed stage I non-small cell lung cancer (NSCLC) that was curatively treated at least 6 months ago, with no evidence of recurrence or second primary tumor, and smoked for at least 10 pack years



• Quit smoking at least 1 year ago

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior cytotoxic chemotherapy

Endocrine therapy

• No concurrent systemic corticosteroids

Radiotherapy

• No prior radiotherapy to the chest

Surgery

• See Disease Characteristics

Other

• More than 3 months since prior chemopreventive drugs (e.g., retinoids)
• More than 3 weeks since prior NSAIDs
• More than 3 months since prior photosensitizing agents (e.g., hematoporphyrin derivative)
• No concurrent NSAIDs (except baby aspirin)
• No concurrent warfarin
• No concurrent medications known to alter or be affected by the alteration of hepatic enzyme p450 2C9 (e.g., fluconazole)

Patient Characteristics:

Age

• 45 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Blood chemistry and cell counts normal

Hepatic

• No history of cirrhosis
• No liver dysfunction
• ALT/AST normal
• Alkaline phosphatase normal
• Lactic dehydrogenase normal
• No coagulopathy

Renal

• No renal dysfunction
• BUN normal
• Creatinine normal

Cardiovascular

• No history of significant coronary artery disease
• No unstable angina

Pulmonary

• No end-stage respiratory disease

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior gastrointestinal ulceration, bleeding, or perforation
• No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No known hypersensitivity to celecoxib, sulfonamides, aspirin, or other non-steroidal anti-inflammatory drugs (NSAIDs)
• No other concurrent medical condition that would preclude study participation

Expected Enrollment

A total of 180 patients (90 per treatment arm) will be accrued for this study.

Outcomes

Modulation of the ki-67 labeling index
Phenotypic modulation of the bronchial histology

Evidence of molecular/genetic aberrations
Changes indicative of response to treatment in the targeted signaling pathway
Parameters that reflect the overall balance of the epigenetic phenomenon thought to facilitate or promote tumorigenesis

Outline

This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to presence of preinvasive lesions (yes vs no). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral placebo twice daily for 6 months followed by oral celecoxib twice daily for 6 months.



• Arm II: Patients receive oral celecoxib twice daily for 6 months followed by oral placebo twice daily for 6 months.

Treatment in both arms continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed every 6 months during treatment and then annually for up to 4 years.

Patients are followed annually for up to 4 years.

Trial Contact Information

Trial Lead Organizations

Jonsson Comprehensive Cancer Center at UCLA

Jenny Mao, MD, Protocol chair		Ph: 310-825-3100; 888-798-0719

U.S.A.
California
	Los Angeles
	Jonsson Comprehensive Cancer Center at UCLA
		Clinical Trials Office - Jonsson Comprehensive Cancer Center at UCLA	Ph:  888-798-0719

Registry Information
Official Title		Lung Cancer Chemoprevention With Celecoxib In Ex-Smokers
Trial Start Date		2002-10-17
Registered in ClinicalTrials.gov		NCT00055978
Date Submitted to PDQ		2003-01-28
Information Last Verified		2007-06-03
NCI Grant/Contract Number		CA16042, CA096134