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

NCT00233935 | Completed Phase 1

• 8 other identifiers: NCI-2009-00855CDR0000653460CDR0000429486IRB-AAAB04072004-0907MDA03-1-01N01CN35159P30CA013696
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Barrett Esophagus

Outcome Measures

Primary Outcomes (1)

• Toxicity defined according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (Version 3.0)

  Up to 6 months

Secondary Outcomes (1)

• Dose-related biologic effects and pharmacodynamic properties of Poly E

  Up to 6 months

Study Arms (4)

Arm I (1 capsule)

EXPERIMENTAL

Patients receive 1 capsule of defined green tea catechin extract PO BID for the next 6 months.

Drug: defined green tea catechin extract

Arm II (2 capsules)

EXPERIMENTAL

Patients receive 2 capsules of defined green tea catechin extract PO BID for the next 6 months.

Drug: defined green tea catechin extract

Arm III (3 capsules)

EXPERIMENTAL

Patients receive 3 capsules of defined green tea catechin extract PO BID for the next 6 months.

Drug: defined green tea catechin extract

Arm IV (placebo)

PLACEBO COMPARATOR

Patients receive 1-3 capsules of placebo PO BID for the next 6 months.

Other: placebo

Interventions

placebo OTHER

Given PO

Also known as: PLCB

Arm IV (placebo)

defined green tea catechin extract DRUG

Given PO

Also known as: Polyphenon E

Arm I (1 capsule); Arm II (2 capsules); Arm III (3 capsules)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (3)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Weill Medical College of Cornell University

New York, New York, 10065, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Interventions

polyphenon E

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Charles Lightdale

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2005
• First Posted: October 6, 2005
• Study Start: November 1, 2005
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: September 11, 2014

Record last verified: 2013-04

Locations

US (3)