Status:
COMPLETED
Celecoxib as a Chemopreventive Agent in Current and Former Smokers
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Smoking
Prevention
Eligibility:
All Genders
18-74 years
Phase:
PHASE3
Brief 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 exami...
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 lun...
Eligibility Criteria
Inclusion
- Participants must be 18-74 years old.
- Participants must have at least a 20 pack-year history of smoking.
- 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.
- Participants must have no contraindications for undergoing bronchoscopy.
- Participants must have no active pulmonary infections.
- 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.)
- 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 %.
- Participants must complete the pretreatment evaluation and must consent to bronchoscopy and to endobronchial biopsy for documentation of histologic status.
- Participants must sign a study-specific informed consent form.
Exclusion
- Participants with active gastric or duodenal ulcers or a history of ulcers requiring prophylactic H2 blockers.
- Participants with active pulmonary infections or recent history of pulmonary infection (within 1 month).
- Participants receiving inhaled steroid therapy on a regular basis.
- Participants with acute intercurrent illness, or participants who had surgery within the preceding 4 weeks unless they have fully recovered.
- Participants requiring chronic ongoing treatment with NSAIDs.
- Participants who are allergic to aspirin or sulfanamides.
- Participants with history of stroke, transient ischemic attack, uncontrolled hypertension, and/or angina pectoris.
- Participants who are pregnant and/or breast-feeding.
- Participants (men or women) of childbearing potential who are not using an effective method of contraception.
- History of cardiovascular diseases that might include one of the following: myocardial infarction, angina, coronary angioplasty, congestive heart failure, stroke, or coronary bypass surgery.
- Diagnosis of diabetes
- 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.
- 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.
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT00981201
Start Date
November 1 2001
End Date
September 1 2009
Last Update
August 1 2012
Active Locations (1)
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1
U.T. M.D. Anderson Cancer Center
Houston, Texas, United States, 77030