Celecoxib as a Chemopreventive Agent in Current and Former Smokers

NCT00981201 | Completed Phase 3

• 1 other identifier: ID00-230
• Study Type: interventional
• Target: 219
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Smoking; Prevention

Keywords

Smoking; Cancer Prevention; Celecoxib; Celebrex; Placebo

Outcome Measures

Primary Outcomes (1)

• The change of the proliferation marker Ki-67.

  From baseline to 3-month visit.

Secondary Outcomes (1)

• The changes in tissue COX-2 expression, lavage PGE2 levels, and genetic markers such as LOH, chromosome instability, and chromosome polysomy.

  3-months and 6-months

Study Arms (4)

Celecoxib + Placebo

EXPERIMENTAL

Drug: Celecoxib; Drug: Placebo

Celecoxib + Celecoxib

EXPERIMENTAL

Drug: Celecoxib

Placebo + Celecoxib

ACTIVE COMPARATOR

Drug: Celecoxib; Drug: Placebo

Placebo + Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Celecoxib DRUG

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.)

Also known as: Celebrex

Celecoxib + Celecoxib; Celecoxib + Placebo

Placebo DRUG

Months 1-3: By mouth twice daily.

Placebo + Celecoxib; Placebo + Placebo

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T. M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Smoking

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jonathan M. Kurie, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2009
• First Posted: September 22, 2009
• Study Start: November 1, 2001
• Primary Completion: July 1, 2007
• Study Completion: September 1, 2009
• Last Updated: August 1, 2012

Record last verified: 2009-09

Locations

US (1)