Phase II Trial of Polyphenon E in Former Smokers With Abnormal Sputa
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Changes in oncogene/tumor suppression gene expression (part 1; completed March 22, 2006)
36 months
No
Stephen Lam, MD
Study Chair
British Columbia Cancer Agency
United States: Food and Drug Administration
CDR0000578191
NCT00573885
January 2008
December 2008
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