Phase I Drug Interaction Clinical Study of Polyphenon E
18 Years
N/A
Both
Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
Phase I Drug Interaction Clinical Study of Polyphenon E
OBJECTIVES:
Primary
- Determine the effect of green tea extract (Polyphenon E) on cytochrome P450 enzyme
activities and glutathione S-transferase activities and levels in healthy participants.
Secondary
- Determine the safety and tolerability of this drug in these participants.
OUTLINE: This is an open-label study.
Participants receive oral green tea extract (Polyphenon E) once daily for 4 weeks in the
absence of unacceptable toxicity.
Participants are followed for 2 weeks.
PROJECTED ACCRUAL: A total of 44 participants will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Healthy individuals
- Non-smokers
- More than 1 year since smoking cessation
- No concurrent smokers
- No regular consumption of large amounts of alcohol
- On average, ≤ 3 alcoholic drinks per week
- Consumes < 6 cups or glasses of tea per week
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance Status
- Not specified
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin ≤ 2.0 mg/dL
- AST or ALT ≤ 2 times normal
- Alkaline phosphatase ≤ 2 times normal
Renal
- Creatinine ≤ 1.5 mg/dL
Cardiovascular
- Resting systolic blood pressure ≥ 100 mm Hg
- No hypertension or hypercholesterolemia requiring unscheduled medical visits or
changes in treatment within the past 3 months
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Willing to refrain from tea and related products and oral herbal/botanical
supplements during study participation
- Willing to limit the consumption of cruciferous vegetables to ≤ once a week during
study participation
- Willing to refrain from caffeine-containing food or beverages (e.g., coffee, colas,
chocolate, or over-the-counter medications) for 72 hours before, during, and for 8
hours after study drug administration
- Willing to refrain from food items that affect drug or carcinogen metabolizing
enzymes (e.g., grapefruit, grapefruit juice, cruciferous vegetables, and food cooked
over charcoal) for 72 hours before, during, and for 8 hours after study drug
administration
- No difficulty swallowing capsules or tablets
- No metabolic disorder known to affect study drugs
- No other serious acute or chronic disease (e.g., type I or II diabetes, cystic
fibrosis, or active infection)
- No known hypersensitivity to green tea or probe drugs (e.g., caffeine,
dextromethorphan, losartan, or buspirone)
- No invasive cancer (i.e., non-skin cancer) within the past 5 years
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- More than 3 months since prior participation in another clinical intervention study
- No concurrent medications or supplements that are known P450 enzyme inducers or
inhibitors
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Prevention
Principal Investigator
H. H. Sherry Chow, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Arizona
Authority:
United States: Federal Government
Study ID:
CDR0000387801
NCT ID:
NCT00091325
Start Date:
October 2004
Completion Date:
Related Keywords:
- Unspecified Adult Solid Tumor, Protocol Specific
- unspecified adult solid tumor, protocol specific
Name | Location |
|---|---|
| Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
