Defined Green Tea Catechin Extract in Preventing Esophageal Cancer in Patients With Barrett's Esophagus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00233935
First received: October 5, 2005
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

The goal of this clinical research study is to test the safety of defined green tea catechin extract at different dose levels. Researchers also want to find out what effects, good and bad, it may have on individual and their risk for esophagus cancer. Esophagus cancer is an increased risk associated with Barrett's esophagus. Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of defined green tea catechin extract may prevent esophageal cancer.


Condition Intervention Phase
Barrett Esophagus
Other: placebo
Drug: defined green tea catechin extract
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Phase Ib Randomized, Double-Blinded, Placebo-Controlled, Dose Escalation Study of Polyphenon E in Patients With Barrett's Esophagus

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Toxicity defined according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (Version 3.0) [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Dose-related biologic effects and pharmacodynamic properties of Poly E [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Generalized linear models will be used.


Enrollment: 55
Study Start Date: November 2005
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (1 capsule)
Patients receive 1 capsule of defined green tea catechin extract PO BID for the next 6 months.
Drug: defined green tea catechin extract
Given PO
Other Name: Polyphenon E
Experimental: Arm II (2 capsules)
Patients receive 2 capsules of defined green tea catechin extract PO BID for the next 6 months.
Drug: defined green tea catechin extract
Given PO
Other Name: Polyphenon E
Experimental: Arm III (3 capsules)
Patients receive 3 capsules of defined green tea catechin extract PO BID for the next 6 months.
Drug: defined green tea catechin extract
Given PO
Other Name: Polyphenon E
Placebo Comparator: Arm IV (placebo)
Patients receive 1-3 capsules of placebo PO BID for the next 6 months.
Other: placebo
Given PO
Other Name: PLCB

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Histologically-confirmed diagnosis of Barrett's metaplasia within 12 months prior to trial entry
  • Note: The presence of LGD may be subject to disagreement between pathologists; this will not affect trial entry, since patients with or without LGD are eligible to participate; all cases in which there is disagreement regarding the presence of LGD will be reviewed by a third pathologist for histological classification prior to the efficacy analysis
  • Cases of short-segment (less than or equal to 3 cm) Barrett's esophagus must be large enough to allow adequate sampling of tissue without completely resecting the metaplasia
  • ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%)
  • Leukocytes greater than or equal to 3,000/UL
  • Absolute neutrophil count greater than or equal to 1,500/UL
  • Platelets greater than or equal to 100,000/UL
  • Total bilirubin within normal institutional limits
  • AST (SGOT)/ALT (SGPT) less than or equal to institutional ULN
  • Creatinine within normal institutional limits
  • Alkaline phosphatase less than or equal to the institutional ULN
  • Willingness to abstain from all tea consumption while on the study drug
  • Willingness to record intake of caffeine-containing foods and medications while on the study
  • A significant portion of caffeine intake occurs from "hidden" sources, including medications and foods
  • Study subjects will be provided a list of permissible medications, beverages and foods which contain caffeine
  • Participants may continue therapy with proton pump inhibitors, nonsteroidal anti-inflammatory agents, and celecoxib or rofecoxib
  • Pregnancy testing to within 2 weeks prior to randomization
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
  • If a female participant does become pregnant while on study, she will be removed from the study
  • Willingness to comply with all treatment and follow-up procedures
  • Willingness to wait at least one month since last endoscopic evaluation
  • Ability to understand and willingness to sign a written informed consent document
  • Inclusion of women and minorities: both men and women and members of all races and ethnic groups are eligible for this trial

Exclusion Criteria:

  • Histologically confirmed high-grade dysplasia
  • Histologically confirmed diagnosis of invasive carcinoma of the esophagus
  • Prior endoscopic therapy for Barrett's esophagus, including mucosal ablation, resection and esophagectomy, and photodynamic therapy
  • History of esophageal strictures with moderate-to-severe dysphagia or odynophagia that may interfere with ingestion/swallowing of the study drug
  • Trial participation will be determined by the study investigator after consideration of other factors including severity of dysphagia and odynophagia, necessity for treatment of strictures, and nutritional status
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Poly E
  • Participants may not be receiving any other investigational agents within 30 days prior to randomization or during the study
  • Use of medications, herbs, and vitamin and mineral supplements that contain tea compounds should not be taken while participating in the study and on study drug and for 30 days prior to trial entry
  • If patients are consuming any of these items and would like to participate in this study, then a 30-day voluntary washout will be required
  • Uncontrolled or significant co-morbid illness including, but not limited to, active or serious infection requiring intravenous antibiotics; symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia;
  • Stages Ia or Ib invasive squamous cell carcinoma of the cervix treated by surgery and/or radiation therapy, stage Ia grade 1 adenocarcinoma of the endometrium treated with surgery; patients receiving active chemotherapy or radiation; or psychiatric illness/social situations that would limit compliance with study requirements
  • Participants will not take aspirin, aspirin-containing substances, Coumadin (warfarin), heparin, or iron for 5 days before each endoscopy
  • Active gastrointestinal bleeding; predisposing condition to gastrointestinal bleeding (including but not limited to gastritis, diverticulitis, colitis, and hemorrhoids); active malignancy diagnosed or treated within 5 years, except for squamous cell carcinoma of the skin, basal cell carcinoma of the skin, carcinoma in situ
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00233935

Locations
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
Principal Investigator: Charles Lightdale Columbia University
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00233935     History of Changes
Other Study ID Numbers: NCI-2009-00855, 2004-0907, CDR0000653460, CDR0000429486, IRB-AAAB0407, N01CN35159
Study First Received: October 5, 2005
Last Updated: April 16, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Barrett Esophagus
Esophageal Neoplasms
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Neuroprotective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 01, 2014