Celecoxib as a Chemopreventive Agent in Current and Former Smokers
Condition: Smoking; Prevention
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is:

        -  To examine the effect of celecoxib treatment on Ki-67 expression, a marker of cell
           proliferation, in the bronchial epithelium of current and former smokers.

        -  To examine the toxicity associated with celecoxib administration.

        -  To measure the effect of celecoxib treatment on arachidonic acid metabolites in the
           bronchial epithelium of current and former smokers.
    

Detailed description: 
      COX-2 is an enzyme thought to be involved in the development of some cancer. Celecoxib is a
      COX-2 inhibitor.

      Before treatment begins, participants will have a bronchoscopy (tissue sample from the lung).
      This is taken to see if different elements (biomarkers) in the tissue can predict which
      individuals are at higher risk for developing cancer. In a bronchoscopy a tube will be placed
      through the nose into the lung (while under sedation) to remove tissue samples for laboratory
      analysis (biopsy). Cells will also be collected during the bronchoscopy by spraying the lungs
      with a small amount water and then removing the water (bronchial lavage, bronchial washing).
      In addition, a sputum sample will be taken and the inside of the cheek will be scraped
      (buccal sample).

      A complete physical exam will be performed before beginning treatment and at 1, 2, 3, 4, 5,
      and 6 months. During these visits, participants will be asked questions about tobacco/alcohol
      exposure. Participants will have blood taken before beginning treatment and at 1, 3, 4, and 6
      months. Urine samples will be taken before beginning treatment and at 3 and 6 months. The
      research nurse will also ask participants about any adverse signs or symptoms that they have
      experienced. Participants who smoke will be encouraged to stop smoking. Sources for
      assistance to stop smoking will be provided for all study participants who continue to smoke.

      In this study, participants will be randomly picked (as in the toss of a coin) to be in one
      of four treatment groups. Treatment in this study will last 6 months. Participants in the
      first group will receive a placebo during all 6 months. A placebo is a substance that looks
      like the study drug but is inactive. Participants in the second group will receive a placebo
      during Months 1-3 and Celecoxib during Months 4-6. Participants in the third group will
      receive Celecoxib during Months 1-3 and placebo during Months 4-6. Participants in the fourth
      group will receive Celecoxib during all 6 months. Neither the participant nor the
      participant's doctor will know to which treatment group the participant was assigned.
      Participants have an equal chance of being assigned to any of these groups.

      Participants will take 2 capsules twice a day for the 6-month treatment period. The capsule
      could be either a placebo or the study drug.

      At 3 and 6 months, participants will have a physical exam, blood tests, and a bronchoscopy.
      Participants should take their study medication with a sip of water 2 hours before each
      bronchoscopy with a sip of water. Sputum and buccal samples will also be taken at these
      times. The research nurse will ask participants questions about changes and/or additions to
      the medications.

      This is an investigational study. The use of Celecoxib in the prevention of lung cancer is
      investigational. Up to 250 individuals will take part in this study. All will be enrolled at
      the M. D. Anderson.
    

Intervention name(s): Celecoxib; Celecoxib; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Months 1-3:
As of October, 2003, the starting dose for celecoxib will be 400 mg by mouth twice daily. (Note: Prior to October, 2003, the starting dose for celecoxib was 200 mg by mouth twice daily.); Months 4-6:
As of October, 2003, the starting dose for celecoxib will be 400 mg by mouth twice daily. (Note: Prior to October, 2003, the starting dose for celecoxib was 200 mg by mouth twice daily.); Months 1-3:
By mouth twice daily.; Months 4-6:
By mouth twice daily.
Other intervention name(s): Celebrex; Celebrex
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Smoking; Cancer Prevention; Celecoxib; Celebrex; Placebo