Green Tea Extract in Treating Current or Former Smokers With Bronchial Dysplasia

NCT00611650 | Terminated Phase 2 DMC

• 4 other identifiers: CDR0000578224P01CA096964BCCA-H07-02401H07-02401
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of Polyphenon E, a substance found in green tea, may keep cancer from forming in current or former smokers with bronchial dysplasia. PURPOSE: This randomized phase II trial is studying the side effects and how well green tea extract works in treating current or former smokers with bronchial dysplasia.

Conditions

Lung Cancer; Precancerous Condition; Tobacco Use Disorder

Keywords

non-small cell lung cancer; squamous lung dysplasia; tobacco use disorder

Outcome Measures

Primary Outcomes (1)

• Change in the severity of dysplasia (as defined by WHO criteria) in bronchial biopsy specimens as assessed at baseline and at 3 months

  3 months

Secondary Outcomes (8)

• Change in the morphometric index in bronchial biopsy specimens as assessed at baseline and at 3 months

  3 months

• Change in the concentrations (or grades) of Ki-67, p53, cleaved caspase-3, and VEGF in bronchial biopsy specimens as assessed by immunostaining at baseline and at 3 months

  3 months

• Methylation biomarkers in bronchoalveolar lavage (BAL) cells as assessed at baseline and at 3 months

  3 months

• Oncogene/ tumor suppressor gene expression in bronchial brush cells as assessed by cDNA microarray analysis at baseline and at 3 months

  3 months

• Phase I and II enzyme regulation in bronchial brush cells as assessed by Affymetrix microarray analysis at baseline and at 3 months

  3 months

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral Polyphenon E twice daily for 3 months in the absence of disease progression or unacceptable toxicity.

Drug: defined green tea catechin extract

Arm II

PLACEBO COMPARATOR

Patients receive a placebo twice daily for 3 months in the absence of disease progression or unacceptable toxicity.

Other: placebo

Interventions

defined green tea catechin extract DRUG

Given orally

Arm I

placebo OTHER

Given orally

Arm II

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Current or former smoker who has smoked ≥ 30 pack-years (i.e., 1 pack per day for ≥ 30 years) * A former smoker is defined as one who has stopped smoking for ≥ 1 year * C-reactive protein level \> 1.2 mg/L * One or more areas of dysplasia with a surface diameter \> 1.2 mm on autofluorescence bronchoscopy * No carcinoma in situ or invasive cancer on bronchoscopy * No abnormal spiral chest CT scan suspicious of lung cancer PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Willing to take Polyphenon E or placebo twice a day regularly * Willing to undergo bronchoscopy and spiral chest CT scan * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Creatinine normal * Bilirubin normal * AST and ALT normal * Alkaline phosphatase normal * No chronic active hepatitis or liver cirrhosis * No severe heart disease (e.g., unstable angina or chronic congestive heart failure) * No ongoing gastric ulcer * No acute bronchitis or pneumonia within the past month * No known reaction to xylocaine, salbutamol, midazolam, or alfentanil * No known allergy to green tea and/or corn starch, gelatin, or other nonmedicinal ingredients * No medical condition, such as acute or chronic respiratory failure or bleeding disorder, that, in the opinion of the investigator, could jeopardize patient safety during study participation PRIOR CONCURRENT THERAPY: * No concurrent consumption of \> 7 cups of tea a week * No other concurrent natural health products containing green tea compounds * No concurrent antiarrhythmic agents * No concurrent anticoagulants, such as warfarin or heparin

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• National Cancer Institute (NCI): collaborator
• University of Cincinnati: collaborator

Study Sites (1)

British Columbia Cancer Agency - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms; Precancerous Conditions; Tobacco Use Disorder; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Stephen Lam, MD

  British Columbia Cancer Agency

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2008
• First Posted: February 11, 2008
• Study Start: October 1, 2006
• Primary Completion: June 1, 2011
• Study Completion: July 1, 2011
• Last Updated: March 9, 2012

Record last verified: 2012-03

Locations

CA (1)