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Green Tea Extract in Preventing Esophageal Cancer in Patients With Barrett's Esophagus
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2008
Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00233935
  Purpose

RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of green tea extract may prevent esophageal cancer.

PURPOSE: This phase I trial is studying the side effects and best dose of green tea extract in preventing esophageal cancer in patients with Barrett's esophagus.


Condition Intervention Phase
Esophageal Cancer
Precancerous/Nonmalignant Condition
Drug: defined green tea catechin extract
Phase I

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders
Drug Information available for: Epigallocatechin gallate Catechin
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control
Official Title: Phase IB Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Patients With Barrett's Esophagus

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 40
Study Start Date: June 2006
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of green tea extract (Polyphenon E) in preventing esophageal cancer in patients with Barrett's esophagus.
  • Determine the safety of this drug in these patients.

Secondary

  • Determine the efficacy of this drug, in terms of inhibiting phosphorylation of epidermal growth factor receptor, HER2, or akt, in esophageal mucosa in these patients.
  • Determine the pharmacodynamic profile of this drug in these patients.
  • Determine the efficacy of this drug, in terms of reduction or stabilization of metaplasia and dysplasia of esophageal Barrett's mucosa, in these patients.
  • Determine the efficacy of this drug, in terms of inhibition of p16 methylation and modulation of surrogate biomarkers, eicosanoid levels (including prostaglandin E2), and lipoxygenase profiles in esophageal mucosa in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, dose-escalation study of green tea extract (Polyphenon E). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive 3-5 capsules of oral green tea extract (Polyphenon E) twice daily.
  • Arm II: Patients receive 3-5 capsules of oral placebo twice daily. In both arms, treatment continues for 6 months in the absence of unacceptable toxicity or the development of cancer of the esophagus or other site.

Cohorts of approximately 5 patients receive escalating doses of green tea extract (Polyphenon E) until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 25% of patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed monthly for 6 months.

PROJECTED ACCRUAL: A total of 40 patients (30 for arm I and 10 for arm II) will be accrued for this study within 15 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed Barrett's esophagus (BE)

    • Metaplasia with or without low-grade dysplasia OR indeterminate for dysplasia

      • No high-grade dysplasia
    • Short-segment (≤ 3 cm) BE allowed provided the area is large enough to allow adequate tissue sampling without completely resecting the metaplasia
    • Diagnosed within the past 12 months
  • No invasive carcinoma of the esophagus

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2 OR
  • Karnofsky 60-100%

Life expectancy

  • Not specified

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin normal
  • AST and ALT normal
  • Alkaline phosphatase normal

Renal

  • Creatinine normal

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of allergic reactions attributed to compounds of similar chemical or biologic composition to green tea extract (Polyphenon E)
  • No history of esophageal strictures with moderate-to-severe dysphagia or odynophagia that may interfere with ingestion and/or swallowing of the study drug
  • No active or serious infection requiring IV antibiotics
  • No active gastrointestinal bleeding
  • No active malignancy within the past 5 years except for the following:

    • Basal cell or squamous cell skin cancer
    • Carcinoma in situ
    • Stage IA or IB invasive squamous cell carcinoma of the cervix treated with surgery and/or radiotherapy
    • Stage IA grade 1 endometrial adenocarcinoma treated with surgery
  • No psychiatric illness or social situation that would preclude study compliance
  • No other uncontrolled or significant co-morbid illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • No concurrent radiotherapy

Surgery

  • No prior mucosal ablation, resection, or esophagectomy for BE

Other

  • At least 1 month since prior endoscopic evaluation
  • More than 30 days since prior investigational agents
  • More than 30 days since prior and no concurrent medications, herbs, vitamins, or mineral supplements containing tea compounds
  • Concurrent proton pump inhibitors, nonsteroidal anti-inflammatory agents, and celecoxib or rofecoxib allowed
  • No other prior endoscopic therapy for BE, including photodynamic therapy
  • No other concurrent investigational agents
  • No tea consumption while on study drug
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00233935

Locations
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C     212-305-8615        
New York Weill Cornell Cancer Center at Cornell University Recruiting
New York, New York, United States, 10021
Contact: Clinical Trials Office - New York Weill Cornell Cancer Center     212-746-1848        
United States, Texas
M. D. Anderson Cancer Center at University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Clinical Trials Office - M. D. Anderson Cancer Center at the U     713-792-3245        
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Charles J. Lightdale, MD Herbert Irving Comprehensive Cancer Center
Investigator: Andrew Joe, MD Herbert Irving Comprehensive Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000429486, MDA-03101, MDA-2004-0907, CPMC-AAA0407
Study First Received: October 5, 2005
Last Updated: December 2, 2008
ClinicalTrials.gov Identifier: NCT00233935  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
esophageal cancer
precancerous/nonmalignant condition

Study placed in the following topic categories:
Epigallocatechin gallate
Digestive System Neoplasms
Precancerous Conditions
Esophageal disorder
Gastrointestinal Diseases
Esophageal Neoplasms
Digestive System Abnormalities
Digestive System Diseases
Head and Neck Neoplasms
Gastrointestinal Neoplasms
Barrett Esophagus
Esophageal Diseases
Congenital Abnormalities
Esophageal neoplasm

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009