Celecoxib as a Chemopreventive Agent in Current and Former Smokers

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Celecoxib

Criteria

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.