Green Tea Extract in Treating Patients With Nonmetastatic Bladder Cancer
NCT ID: NCT00666562
Last Updated: 2017-11-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
31 participants
INTERVENTIONAL
2008-07-02
2017-06-09
Brief Summary
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Detailed Description
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SECONDARY OBJECTIVES:
I. To compare the levels of EGCG in nonmalignant versus malignant bladder tissue samples from these patients.
II. To examine the dose-response modulation of surrogate intermediate endpoint biomarkers (e.g., Proliferating Cell Nuclear Antigen \[PCNA\], Matrix Metallopeptidase 2 \[MMP2\], clusterin, Vascular endothelial Growth Factor \[VEGF\], p27, and ODC) in malignant and nonmalignant samples of bladder tissue from these patients after administration of polyphenon E.
III. To correlate EGCG levels in samples of serum, urine, and tissue from these patients.
IV. To examine the levels of other catechins (i.e., epicatechin, epicatechin gallate, and epigallocatechin) found in polyphenon E in samples of serum, urine, and tissue from these patients.
V. To compare the metabolism of EGCG by Catechol-O-Methyltransferase (COMT) and Uridinediphosphate-Glucuronosyltransferase (UGT) in relation to pharmacogenetic polymorphisms in COMT and UGT in samples of serum, urine, and tissue from these patients.
VI. To examine the changes in serum Insulin Growth Factor 1 (IGF-1) and IGFBP-3 levels after administration of polyphenon E in these patients.
OUTLINE:
This is a multicenter study. Patients are stratified according to tumor site and disease invasiveness (invasive vs noninvasive). Patients are randomized to 1 of 3 treatment arms.
Arm I: Patients receive six oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.
Arm II: Patients receive four oral polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.
Arm III: Patients receive six oral polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity.
After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
Blood, urine, and tissue samples are obtained at baseline and at the end of study treatment for correlative laboratory studies. Samples are evaluated for pharmacokinetics of polyphenon E using high performance liquid chromatography. Levels of epigallocatechin-3-gallate \[EGCG\] and other catechins found in polyphenon E are assessed for correlation in serum, urine, and tissue. Intermediate endpoint biomarkers are evaluated for dose-response modulation in serum (i.e., IGF-1 and IGFBP-3) via ELISA and in bladder tissue obtained at the time of bladder surgery (i.e., PCNA, MMP2, clusterin, VEGF, p27, and ODS) via IHC. Patients at the University of Wisconsin undergo additional biopsy of bladder tissue for matrix-assisted laser desorption quadrupole time-of-flight (O-MALDI-qTOF) analysis of EGCG pharmacokinetics. Tissue samples are examined for intracellular concentration and distribution of EGCG. Genotyping studies for pyrosequencing of UGT and COMT polymorphisms are also performed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Arm I (placebo)
Patients receive six oral placebo capsules once daily for 14-28 days.
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Placebo
Given orally
Arm II (polyphenon E, placebo)
Patients receive four oral polyphenon E capsules and two oral placebo capsules once daily for 14-28 days in the absence of unacceptable toxicity.
Defined Green Tea Catechin Extract
Given orally
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Placebo
Given orally
Arm III (polyphenon E, trans-urethral resection or cystectomy)
Patients receive six oral polyphenon E capsules once daily for 14-28 days in the absence of unacceptable toxicity. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.
Defined Green Tea Catechin Extract
Given orally
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Therapeutic Conventional Surgery
Undergo surgery
Interventions
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Defined Green Tea Catechin Extract
Given orally
Laboratory Biomarker Analysis
Correlative studies
Pharmacological Study
Correlative studies
Placebo
Given orally
Therapeutic Conventional Surgery
Undergo surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* TURBT or radical cystectomy is the planned curative surgical treatment
* ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
* More than 30 days since any prior intravesical therapy or adjuvant chemotherapy
* More than 30 days since prior bladder surgery
* Biopsies are not considered surgeries
* No prior pelvic radiotherapy
* No concurrent systemic chemotherapy for any other cancer, except nonmelanoma skin cancer
* No concurrent NSAIDs (e.g., ibuprofen, naproxen, or cyclooxygenase-2 inhibitors) except =\< 81 mg aspirin per day
* Concurrent acetaminophen (Tylenol) or prescription opioids combined with acetaminophen (i.e., Percocet, Darvocet, Vicodin, Tylenol #3) allowed for pain
* No other concurrent investigational agents
* White Blood Cell (WBC) \>= 3,000/mm\^3
* Platelet count \>= 100,000/mm\^3
* Hemoglobin \>= 10 g/dL
* Alkaline phosphatase =\< upper limit of normal (ULN)
* Bilirubin =\< ULN
* Asparate Aminotransferase (AST) and Alanine Transaminase (ALT) =\< ULN
* Sodium 135-144 mmol/L (inclusive)
* Potassium 3.2-4.8 mmol/L (inclusive)
* Chloride 85-114 mmol/L (inclusive)
* Bicarbonate \>11 mEQ/dL
* Negative pregnancy test
* Fertile patients must use effective contraception
* Willing to avoid green tea beverages and green tea-containing products during study participation
* No evidence of other cancers, except nonmelanoma skin cancer
* No history of allergic reactions attributed to tea or to any of the compounds of similar chemical or biologic composition to Polyphenon E or any of the inactive ingredients in Polyphenon E capsules
* No uncontrolled intercurrent illness including, but not limited to, any of the following: Ongoing or active infection, Symptomatic congestive heart failure, Unstable angina pectoris, Cardiac arrhythmia, Psychiatric illness/social situations that would limit study compliance
* More than 24 hours since prior and no concurrent consumption of any other green tea supplements or more than 2 cups (16 oz) of green tea either through dietary sources or through nutritional supplementation
* Topical cosmetics (i.e., lotions, shampoos, makeup) that contain green tea are allowed
* Creatinine normal
* Not pregnant or nursing
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Tracy Downs
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Minneapolis Veterans Medical Center
Minneapolis, Minnesota, United States
University of Rochester
Rochester, New York, United States
Urology San Antonio Research PA
San Antonio, Texas, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Countries
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Other Identifiers
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NCI-2009-00906
Identifier Type: REGISTRY
Identifier Source: secondary_id
CO06810
Identifier Type: -
Identifier Source: secondary_id
CDR0000594276
Identifier Type: -
Identifier Source: secondary_id
H-2007-0250
Identifier Type: -
Identifier Source: secondary_id
UWI06-8-01
Identifier Type: OTHER
Identifier Source: secondary_id
UWI06-8-01
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2009-00906
Identifier Type: -
Identifier Source: org_study_id