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Green Tea Extract in Treating Patients With Nonmetastatic Bladder Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00666562
First received: April 24, 2008
Last updated: July 27, 2016
Last verified: July 2016
  Purpose
Green tea extract contains ingredients that may slow the growth of certain cancers. It is not yet known whether green tea extract is more effective than a placebo when given before surgery in treating patients with bladder. This randomized phase II trial is studying green tea extract to see how well it works compared to a placebo when given before surgery in treating patients with nonmetastatic bladder cancer.

Condition Intervention Phase
Stage I Bladder Cancer
Stage II Bladder Cancer
Stage III Bladder Cancer
Dietary Supplement: Defined Green Tea Catechin Extract
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Placebo
Procedure: Therapeutic Conventional Surgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Phase II Randomized, Placebo-Controlled Trial of Polyphenon E to Evaluate Bladder Tissue Levels of EGCG

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Epigallocatechin Gallate (EGCG) Levels in Nonmalignant Bladder Tissue (e.g., Normal-appearing Urothelium, Inflammatory Lesions in the Bladder, Sessile Noninvasive Bladder Tumors, and Papillary Noninvasive Bladder Tumors) [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
    Comparison of nonmalignant bladder tissue levels of EGCG between the placebo group and the EGCG groups combined using student t-test.


Secondary Outcome Measures:
  • Levels of EGCG in Malignant Bladder Tissue [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
  • Levels of Surrogate Intermediate Endpoint Biomarkers in Malignant and Nonmalignant Bladder Tissue Assessed by Immunohistochemistry [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
  • Serum Insulin Growth Factor-1 (IGF-1) Levels Assessed by ELISA [ Time Frame: Baseline and up to day 28 ] [ Designated as safety issue: No ]
  • Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Tumor Tissue Samples [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
  • Absolute Change for Baseline From EGCG in Serum Samples [ Time Frame: Baseline and up to 28 days ] [ Designated as safety issue: No ]
    The difference between the amount at the end of study (up to 28 days) from baseline.

  • Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Catechol-O-Methyltransferase (COMT) [ Time Frame: At Baseline ] [ Designated as safety issue: No ]
  • Serum IGFBP-3 Levels Assessed by ELISA [ Time Frame: Baseline and up to 28 days ] [ Designated as safety issue: No ]
  • Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Normal Tissue Samples [ Time Frame: up to 28 days ] [ Designated as safety issue: No ]
  • Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E in Urine Samples [ Time Frame: Baseline and up to 28 days ] [ Designated as safety issue: No ]
    The difference between the amount at the end of study (up to 28 days) from baseline.

  • Absolute Change From Baseline of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Plasma Samples [ Time Frame: Baseline and up to 28 days ] [ Designated as safety issue: No ]
    The difference between the amount at the end of study (up to 28 days) from baseline.

  • Absolute Change for Baseline of EGCG in Urine Samples [ Time Frame: Baseline and up to 28 days ] [ Designated as safety issue: No ]
    The difference between the amount at the end of study (up to 28 days) from baseline.

  • Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Uridinediphosphate- Glucuronosyltransferase (UGT) [ Time Frame: At Baseline ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: July 2008
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm I (placebo)
Patients receive six oral placebo capsules once daily for 14-28 days.
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Pharmacological Study
Correlative studies
Drug: Placebo
Given orally
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy
Experimental: 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.
Dietary Supplement: Defined Green Tea Catechin Extract
Given orally
Other Names:
  • Polyphenon E
  • Polyphenon E TM
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Pharmacological Study
Correlative studies
Drug: Placebo
Given orally
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy
Experimental: 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.
Dietary Supplement: Defined Green Tea Catechin Extract
Given orally
Other Names:
  • Polyphenon E
  • Polyphenon E TM
Other: Laboratory Biomarker Analysis
Correlative studies
Other: Pharmacological Study
Correlative studies
Procedure: Therapeutic Conventional Surgery
Undergo surgery

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Criteria:

  • Diagnosis of bladder cancer
  • Bladder tumor discovered on cystoscopy within the past 60 days
  • Invasive or non-invasive tumor
  • Primary tumor may represent either an initial diagnosis or recurrent disease of any clinical stage
  • No metastatic disease
  • Must be an eligible candidate for a partial cystectomy, radical cystectomy, or trans-urethral resection of bladder tumor (TURBT)
  • Has not undergone any treatment for superficial or invasive bladder cancer since the diagnostic cystoscopy
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666562

Locations
United States, Alabama
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
United States, Massachusetts
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
United States, Minnesota
Minneapolis Veterans Medical Center
Minneapolis, Minnesota, United States, 55417
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, Texas
Urology San Antonio Research PA
San Antonio, Texas, United States, 78229
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Tracy Downs University of Wisconsin, Madison
  More Information

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00666562     History of Changes
Other Study ID Numbers: NCI-2009-00906  NCI-2009-00906  CO06810  CDR0000594276  H-2007-0250  UWI06-8-01  UWI06-8-01  N01CN35153  P30CA014520 
Study First Received: April 24, 2008
Results First Received: January 20, 2016
Last Updated: July 27, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents

ClinicalTrials.gov processed this record on September 30, 2016