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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00233935 |
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 |
ChemIDplus related topics: | Epigallocatechin gallate Catechin |
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 |
Estimated Enrollment: | 40 |
Study Start Date: | June 2006 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed Barrett's esophagus (BE)
Metaplasia with or without low-grade dysplasia OR indeterminate for dysplasia
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No active malignancy within the past 5 years except for the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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 |
M.D. Anderson Cancer Center |
National Cancer Institute (NCI) |
Study Chair: | Charles J. Lightdale, MD | Herbert Irving Comprehensive Cancer Center |
Investigator: | Andrew Joe, MD | Herbert Irving Comprehensive Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000429486, MDA-03101, MDA-2004-0907, CPMC-AAA0407 |
First Received: | October 5, 2005 |
Last Updated: | August 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00233935 |
Health Authority: | Unspecified |
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