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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 M.D. Anderson Cancer Center, October 2009
First Received: October 5, 2005   Last Updated: October 13, 2009   History of Changes
Sponsor: M.D. Anderson Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00233935
  Purpose

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

The goal of this clinical research study is to test the safety of Polyphenon E (Poly E) 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 Barret's Esophagus.


Condition Intervention Phase
Esophageal Cancer
Barrett's Esophagus
Dietary Supplement: Polyphenon E (Poly E)
Other: Placebo
Phase I

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
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 M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Maximum tolerated dose (MTD) of Poly E [ Time Frame: Baseline to 6 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: June 2006
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Poly E: Experimental
3-5 capsules of oral green tea extract (Polyphenon E) twice daily
Dietary Supplement: Polyphenon E (Poly E)
3-5 capsules of oral green tea extract (Polyphenon E) twice daily for 6 months.
Placebo: Placebo Comparator
3-5 capsules of oral placebo twice daily.
Other: Placebo
3-5 capsules of oral placebo twice daily for 6 months.

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. 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.
  2. Cases of short-segment (less than or equal to 3cm) Barrett's esophagus must be large enough to allow adequate sampling of tissue without completely resecting the metaplasia.
  3. Age greater than or equal to 18 years.
  4. ECOG performance status less than or equal to 2 (Karnofsky greater than or equal to 60%)
  5. Participants must have normal organ and marrow function as defined below: 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.
  6. Willingness to abstain from all tea consumption while on the study drug.
  7. 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.
  8. Participants may continue therapy with proton pump inhibitors, nonsteroidal anti-inflammatory agents, and celecoxib or rofecoxib.
  9. 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.
  10. Willingness to comply with all treatment and follow-up procedures.
  11. Willingness to wait at least one month since last endoscopic evaluation.
  12. Ability to understand and willingness to sign a written informed consent document.
  13. Inclusion of Women and Minorities. Both men and women and members of all races and ethnic groups are eligible for this trial.

Exclusion Criteria:

  1. Histologically confirmed high-grade dysplasia.
  2. Histologically confirmed diagnosis of invasive carcinoma of the esophagus.
  3. Prior endoscopic therapy for Barrett's esophagus, including mucosal ablation, resection and esophagectomy, and photodynamic therapy.
  4. 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.
  5. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Poly E.
  6. Participants may not be receiving any other investigational agents within 30 days prior to randomization or during the study.
  7. 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.
  8. 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; 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,
  9. Continued from # 8. 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.
  10. Participants will not take aspirin, aspirin-containing substances, coumadin (warfarin), heparin, or iron for 5 days before each endoscopy.
  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
Principal Investigator: Andrew Joe, MD Herbert Irving Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: UT MD Anderson Cancer Center ( Robert S. Bresalier, MD / Professor )
Study ID Numbers: 2004-0907, CDR0000429486, MDA-03101, MDA-2004-0907, CPMC-AAA0407
Study First Received: October 5, 2005
Last Updated: October 13, 2009
ClinicalTrials.gov Identifier: NCT00233935     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Esophageal cancer
Esophagus
Precancerous/nonmalignant condition
low-grade dysplasia
LGD
Polyphenon E
Green Tea extract

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Digestive System Abnormalities
Gastrointestinal Diseases
Head and Neck Neoplasms
Esophageal Neoplasms
Gastrointestinal Neoplasms
Barrett Esophagus
Esophageal Diseases

ClinicalTrials.gov processed this record on February 08, 2010