Clinical Trial: Green Tea Extract in Preventing Esophageal Cancer in Patients With Barrett''s Esophagus

This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) October 2005

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 Condition
 Drug: green tea extract
 Procedure: biologically based therapies
 Procedure: cancer prevention intervention
 Procedure: chemoprevention of cancer
 Procedure: complementary and alternative therapy
 Procedure: herbal medicine / botanical therapy
Phase I

MedlinePlus related topics:  Cancer;   Cancer Alternative Therapies;   Esophageal Cancer

Study Type: Interventional
Study Design: Prevention

Official Title: Phase IB Randomized Study of Green Tea Extract (Polyphenon E) in Preventing Esophageal Cancer in Patients With Barrett’s Esophagus

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

OBJECTIVES:

Primary

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 above,  Genders Eligible for Study:  Both
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 6 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 ≤ 2.5 times upper limit of 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 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

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 or caffeine
  • 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 concurrent tea consumption
  • No concurrent consumption of more than two 8-ounce cups of regular coffee per day
  • Total daily caffeine consumption ≤ 250 mg/day
  • Concurrent consumption of decaffeinated coffee is allowed

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00233935


Study chairs or principal investigators

Charles J. Lightdale, MD,  Study Chair,  Herbert Irving Comprehensive Cancer Center   
Scott M. Lippman, MD, FACP,  Principal Investigator,  M.D. Anderson Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000429486; MDA-03101
Last Updated:  December 8, 2005
Record first received:  October 5, 2005
ClinicalTrials.gov Identifier:  NCT00233935
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10



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