NCT00055978

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P75+ for phase_2 lung-cancer

Timeline
Completed

Started Oct 2002

Typical duration for phase_2 lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 7, 2003

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

June 20, 2011

Status Verified

June 1, 2011

Enrollment Period

5.4 years

First QC Date

March 6, 2003

Last Update Submit

June 16, 2011

Conditions

Lung Cancer

Keywords

non-small cell lung cancerstage I non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

  • Modulation of the ki-67 labeling index

    5 years

  • Phenotypic modulation of the bronchial histology

    5 years

Secondary Outcomes (3)

  • Evidence of molecular/genetic aberrations

    5 years

  • Changes indicative of response to treatment in the targeted signaling pathway

    5 years

  • Parameters that reflect the overall balance of the epigenetic phenomenon thought to facilitate or promote tumorigenesis

    5 years

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral placebo twice daily for 6 months.

Other: placebo

Arm II

EXPERIMENTAL

Patients receive oral celecoxib twice daily for 6 months.

Drug: celecoxib

Interventions

celecoxibDRUG

Given orally. 400mg twice daily for 6 months.

Also known as: Celebrex, Celebra
Arm II
placeboOTHER

Given orally

Arm I

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Heavy former smokers without prior history of NSCLC
  • Age \> 45
  • Smoked for minimum of 30 pack years
  • Former smokers with prior curative resection of surgical stage I NSCLC will be recruited and must be:
  • Age \> 18
  • Smoked \> 10 pack years
  • Must have had pathological staging and the extent of disease documented. At least one nodal station each must have been biopsied and all biopsies must have been negative
  • At least 6 months post curative resection of Stage I prior NSCLC, without evidence for recurrence or second primary lung cancer
  • Normal blood chemistry and cell counts
  • Negative pregnancy test

You may not qualify if:

  • Framingham 10-year-risk for coronary artery disease score \> 10%
  • History of cardiovascular disease
  • Evidence of diffuse coronary calcification on screening CT
  • Concurrent use of NSAIDs. The use of cardiac (baby) Aspirin is permitted
  • Hypersensitivity to celecoxib, sulfonamides, aspirin or other NSAIDs
  • Liver dysfunction \[abnormally elevated liver function tests \[transaminases (ALT, AST) \> ULN, alkaline phosphatase (ALKP) \> 1.5 ULN\]\] or history of cirrhosis
  • No peptic ulcer disease (PUD) diagnosis nor active symptoms in the last 2 years or, if PUD was diagnosed \< 2 years, there must be no active symptoms, and endoscopic confirmation of healing
  • Renal dysfunction \[abnormally elevated blood urea nitrogen (BUN) \> 1.5 ULN and creatinine \> ULN\]
  • End state respiratory disease
  • Unstable angina or a history of significant coronary artery disease
  • Other malignancies excluding non-melanoma type skin cancer and in situ cervical cancer. Persons with stage I/II head and neck cancer must be disease free for at least 12 months
  • Pregnancy
  • Lactation
  • Unwillingness to practice contraception
  • On systemic corticoid steroid therapy
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jenny T. Mao, MD

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 6, 2003

First Posted

March 7, 2003

Study Start

October 1, 2002

Primary Completion

March 1, 2008

Study Completion

May 1, 2009

Last Updated

June 20, 2011

Record last verified: 2011-06

Locations

US(1)