Green Tea Extract in Preventing Esophageal Cancer in Patients With Barrett''s Esophagus - Article Botanicals; Herbalism; Medicinal Herbs
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
|Esophageal Cancer |
| 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
- Determine the maximum tolerated dose of green tea extract (Polyphenon E) in preventing esophageal cancer in patients with Barrett’s esophagus.
- Determine the safety of this drug in these patients.
- 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.
- 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
- 18 and over
- ECOG 0-2 OR
- Karnofsky 60-100%
- Not specified
- WBC ≥ 3,000/mm^3
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal
- Creatinine normal
- 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:
- Not specified
- No concurrent chemotherapy
- Not specified
- No concurrent radiotherapy
- No prior mucosal ablation, resection, or esophagectomy for BE
- 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
Charles J. Lightdale, MD, Study Chair, Herbert Irving Comprehensive Cancer Center
Scott M. Lippman, MD, FACP, Principal Investigator, M.D. Anderson Cancer Center
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