A Randomized, Double-Blind Study of the Biological Effects and Tolerability of Celecoxib as a Chemopreventive Agent in Current and Former Smokers
COX-2 is an enzyme thought to be involved in the development of some cancer. Celecoxib is a
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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
The change of the proliferation marker Ki-67.
From baseline to 3-month visit.
Jonathan M. Kurie, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|U.T. M.D. Anderson Cancer Center||Houston, Texas 77030|