Celecoxib in Preventing Lung Cancer in Former Heavy Smokers - Full Text View

Sponsor:	Jonsson Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00055978

Purpose

RATIONALE: Chemoprevention therapy uses certain drugs to try to prevent the development or recurrence of cancer. Celecoxib may be effective in preventing the development or recurrence of lung cancer in former heavy smokers.

PURPOSE: Randomized phase II trial to study the effectiveness of celecoxib in preventing the development or recurrence of lung cancer in former heavy smokers who are at risk of developing cancer.

Condition	Intervention	Phase
Lung Cancer	Drug: celecoxib Other: placebo	Phase II

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control
Official Title:	Lung Cancer Chemoprevention With Celecoxib In Ex-Smokers

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Celecoxib

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Modulation of the ki-67 labeling index [ Designated as safety issue: No ]
Phenotypic modulation of the bronchial histology [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evidence of molecular/genetic aberrations [ Designated as safety issue: No ]
Changes indicative of response to treatment in the targeted signaling pathway [ Designated as safety issue: No ]
Parameters that reflect the overall balance of the epigenetic phenomenon thought to facilitate or promote tumorigenesis [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	October 2002
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients receive oral placebo twice daily for 6 months followed by oral celecoxib twice daily for 6 months.	Drug: celecoxib Given orally Other: placebo Given orally
Arm II: Experimental Patients receive oral celecoxib twice daily for 6 months followed by oral placebo twice daily for 6 months.	Drug: celecoxib Given orally Other: placebo Given orally

Detailed Description:

OBJECTIVES:

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

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.

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

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00055978

Locations

United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781

Sponsors and Collaborators

Jonsson Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Jenny T. Mao, MD

Jonsson Comprehensive 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:	Jonsson Comprehensive Cancer Center at UCLA ( Jenny T. Mao )
Study ID Numbers:	CDR0000271912, UCLA-0108074
Study First Received:	March 6, 2003
Last Updated:	June 5, 2009
ClinicalTrials.gov Identifier:	NCT00055978 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

non-small cell lung cancer
stage I non-small cell lung cancer

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Thoracic Neoplasms
Respiratory Tract Neoplasms
Celecoxib
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site

Respiratory Tract Diseases
Sensory System Agents
Analgesics, Non-Narcotic
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 25, 2009