Celecoxib in Preventing Non-Small Cell Lung Cancer in Tobacco Smokers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00020878
First received: July 11, 2001
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Celecoxib may be effective in preventing lung cancer in tobacco smokers.

PURPOSE: Phase II trial to study the effectiveness of celecoxib in preventing non-small cell lung cancer in tobacco smokers.


Condition Intervention Phase
Lung Cancer
Drug: celecoxib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Celecoxib for Chemoprevention of Primary Lung Cancer

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • Evaluate the expression of Cox-2 and PGE2 in the lungs of tobacco smokers. [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Evaluate the capacity for an oral Cox-2 inhibitor (Celecoxib) to suppress the intrapulmonary formation of PGE2 [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Determine the effects of Cox-2 inhibition on biomarkers of field cancerization on histopathologic abnormalities in patients at risk for primary NSCLC [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Study the potential role of PGE2 and its regulation by Cox-2 specific inhibitors on antitumor immunity within the lung microenvironment [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: March 2001
Study Completion Date: May 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study
See intervention description.
Drug: celecoxib
Dosing will occur for a total of 6 months. 400 mg by mouth twice daily.
Other Name: Celebrex

Detailed Description:

OBJECTIVES:

  • Determine the efficacy and feasibility of celecoxib for chemoprevention of primary non-small cell lung cancer in high-risk tobacco smokers.
  • Determine the safety and long-term side effects of this drug in this population.

OUTLINE: Patients receive oral celecoxib twice daily for 6 months.

Patients are followed at 2 weeks and then at 6 months.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study within 6 months.

  Eligibility

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

Inclusion Criteria:

  • Age > 45
  • Smoked > 20 pack years

Exclusion Criteria:

  • Concurrent use of NSAIDs
  • Hypersensitivity to celecoxib
  • Documented allergic-type reaction to sulfonamides
  • History of allergic reaction, urticaria or asthma to aspirin or other NSAIDs
  • History of liver dysfunction
  • Hypertension or cardiac conditions aggravated by fluid retention and edema
  • Previous history of gastrointestinal ulceration, bleeding, or perforation
  • Renal dysfunction
  • End stage respiratory disease
  • Unstable angina
  • Other malignancy
  • Pregnancy
  • Concurrent use of medication known to alter or be affected by alteration of the hepatic p450 2C9 and 2D6 enzymes
  • Patents with concurrent medical conditions that may interfere with completion of tests, therapy, or the follow up schedule
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00020878

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Jenny T. Mao, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00020878     History of Changes
Other Study ID Numbers: CDR0000068727, P30CA016042, UCLA-0012067, NCI-G01-1966
Study First Received: July 11, 2001
Last Updated: July 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Jonsson Comprehensive Cancer Center:
non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014