A Randomized, Double-Blind Study of the Biological Effects and Tolerability of Celecoxib as a Chemopreventive Agent in Current and Former Smokers
18 Years
74 Years
Both
Smoking, Prevention
Trial Information
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
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.
Inclusion Criteria:
1. Participants must be 18-74 years old.
2. Participants must have at least a 20 pack-year history of smoking.
3. Participants may have had a prior laryngeal cancer (Stage I or II) that was
completely resected or rendered disease-free by radiation therapy, or a prior lung
cancer (Stage I NSCLC) that was completely resected, without radiotherapy.
Participants must have been clinically free of any cancer for at least 6 months.
4. Participants must have no contraindications for undergoing bronchoscopy.
5. Participants must have no active pulmonary infections.
6. Participants must not be taking inhaled steroids or oral non-steroidal
anti-inflammatory drugs on a regular basis. (Low dose aspirin <= 81 mg/day is
allowed.)
7. Participants must have the following blood levels: total granulocyte count > 1500;
platelet count > 100,000; total bilirubin <= 1.5 mg %; and creatinine <= 1.5 mg %.
8. Participants must complete the pretreatment evaluation and must consent to
bronchoscopy and to endobronchial biopsy for documentation of histologic status.
9. Participants must sign a study-specific informed consent form.
Exclusion Criteria:
1. Participants with active gastric or duodenal ulcers or a history of ulcers requiring
prophylactic H2 blockers.
2. Participants with active pulmonary infections or recent history of pulmonary
infection (within 1 month).
3. Participants receiving inhaled steroid therapy on a regular basis.
4. Participants with acute intercurrent illness, or participants who had surgery within
the preceding 4 weeks unless they have fully recovered.
5. Participants requiring chronic ongoing treatment with NSAIDs.
6. Participants who are allergic to aspirin or sulfanamides.
7. Participants with history of stroke, transient ischemic attack, uncontrolled
hypertension, and/or angina pectoris.
8. Participants who are pregnant and/or breast-feeding.
9. Participants (men or women) of childbearing potential who are not using an effective
method of contraception.
10. History of cardiovascular diseases that might include one of the following:
myocardial infarction, angina, coronary angioplasty, congestive heart failure,
stroke, or coronary bypass surgery.
11. Diagnosis of diabetes
12. History of deep venous thrombosis, pulmonary embolism, systemic lupus erythematous,
family history of protein S or C deficiencies, prior heparin-induced
thrombocytopenia, or known Factor V Leiden mutation.
13. Family history of premature CAD. This is defined as individuals with either: 1)
father with MI prior to age 55, or 2) mother with MI prior to age 60.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Outcome Measure:
The change of the proliferation marker Ki-67.
Outcome Time Frame:
From baseline to 3-month visit.
Safety Issue:
No
Principal Investigator
Jonathan M. Kurie, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
ID00-230
NCT ID:
NCT00981201
Start Date:
November 2001
Completion Date:
September 2009
Related Keywords:
- Smoking
- Prevention
- Smoking
- Cancer Prevention
- Celecoxib
- Celebrex
- Placebo
- Smoking
Name | Location |
|---|---|
| U.T. M.D. Anderson Cancer Center | Houston, Texas 77030 |
