Green Tea Extract in Preventing Cancer in Former and Current Heavy Smokers With Abnormal Sputum
Condition: Lung Cancer; Tobacco Use Disorder
MeSH terms: Lung Neoplasms; Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. Green tea
      extract may keep cancer from forming.

      PURPOSE: This randomized phase II trial is studying green tea extract in preventing cancer in
      former and current heavy smokers with abnormal sputum.
    

Detailed description: 
      OBJECTIVES:

        -  Evaluate the efficacy and safety of defined green tea catechin extract (polyphenon E) in
           former smokers with abnormal sputum score using stringent, newly developed response
           criteria of combined nuclear morphometry and malignancy-associated changes as the
           primary surrogate endpoint.

        -  Evaluate if polyphenon E can modulate other surrogate endpoint biomarkers of aberrant
           methylation, cell cycle regulation, apoptosis, oncogene/tumor suppressor gene
           expression, as well as phase I and II enzyme regulation.

        -  Establish a library of in-vivo confocal micro-endoscopy and optical coherent tomography
           images of the bronchial epithelium with corresponding histopathology, nuclear
           morphometry, and other biomarker information to assess the potential of confocal
           micro-endoscopy as a non-biopsy method to assess the effect of chemoprevention agents.

      OUTLINE: This is an open label, part 1 study followed by a randomized, double-blind, part 2
      study.

        -  Part 1 (completed March 22, 2006): Patients receive oral defined green tea catechin
           extract twice daily in months 1 and 2 and inhaled budesonide twice daily in month 2.

      Patients undergo autofluorescence bronchoscopy with biopsies, oral and bronchial brushing,
      and bronchoalveolar lavage at the end of months 1 and 2.

        -  Part 2: Patients are stratified by gender and randomized to 1 of 2 treatment arms.

             -  Arm I: Patients receive oral defined green tea catechin extract twice daily for 6
                months.

             -  Arm II: Patients receive oral placebo twice daily for 6 months. Patients who have
                progressive or stable disease at 6 months may receive open-label defined green tea
                catechin extract.

      Patients undergo autofluorescence bronchoscopy with biopsies, oral and bronchial brushing,
      and bronchoalveolar lavage at the end of months 6 and 12.

      Blood samples are collected periodically for biomarker studies. After completion of study
      therapy, patients are followed periodically for 6 months.
    

Intervention name(s): defined green tea catechin extract; placebo
Intervention type(s): Drug; Other
Intervention description(s): Given orally; Given orally
Intervention MeSH terms: Epigallocatechin gallate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: non-small cell lung cancer; small cell lung cancer; tobacco use disorder