NCT00981201

Celecoxib as a Chemopreventive Agent in Current and Former Smokers

A Randomized, Double-Blind Study of the Biological Effects and Tolerability of Celecoxib as a Chemopreventive Agent in Current and Former Smokers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 219 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Accepted

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.

Conditions

• Smoking
• Prevention

Interventions

Type	Name	Description
DRUG	Celecoxib	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.)
DRUG	Celecoxib	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.)
DRUG	Placebo	Months 1-3: By mouth twice daily.
DRUG	Placebo	Months 4-6: By mouth twice daily.

Timeline

• Start date: 2001-11-01
• Primary completion: 2007-07-01
• Completion: 2009-09-01
• First posted: 2009-09-22
• Last updated: 2012-08-01

Locations

1 site across 1 country: United States