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: March 28, 2016
Last verified: February 2016
Results First Received: January 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Stage I Bladder Cancer
Stage II Bladder Cancer
Stage III Bladder Cancer
Interventions: Dietary Supplement: Defined Green Tea Catechin Extract
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
Drug: Placebo
Procedure: Therapeutic Conventional Surgery

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited during a 4 year period by staff at 5 participating institutions (both University hospitals and community clinics).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I (Placebo)

Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Arm II (800mg Polyphenon E, Placebo)

Patients receive four oral 800mg polyphenon E capsules and two oral placebo 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

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Arm III (1200mg Polyphenon E)

Patients receive six oral 1200mg 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

therapeutic conventional surgery: Undergo surgery

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies


Participant Flow:   Overall Study
    Arm I (Placebo)     Arm II (800mg Polyphenon E, Placebo)     Arm III (1200mg Polyphenon E)  
STARTED     11     10     10  
COMPLETED     11     8     10  
NOT COMPLETED     0     2     0  
Withdrawal by Subject                 0                 1                 0  
Concomitant Medication                 0                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Arm I (Placebo)

Patients receive six oral placebo capsules once daily for 14-28 days. After completion of study treatment, patients undergo trans-urethral resection of bladder tumor or cystectomy.

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Arm II (800mg Polyphenon E, Placebo)

Patients receive four oral 800mg polyphenon E capsules and two oral placebo 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

placebo: Given orally

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Arm III (1200mg Polyphenon E)

Patients receive six oral 1200mg 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

therapeutic conventional surgery: Undergo surgery

pharmacological study: Correlative studies

laboratory biomarker analysis: Correlative studies

Total Total of all reporting groups

Baseline Measures
    Arm I (Placebo)     Arm II (800mg Polyphenon E, Placebo)     Arm III (1200mg Polyphenon E)     Total  
Number of Participants  
[units: participants]
  11     10     10     31  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     3     7     3     13  
>=65 years     8     3     7     18  
Age  
[units: years]
Mean (Standard Deviation)
  70.00  (7.04)     65.20  (9.50)     66.20  (9.55)     67.23  (8.69)  
Gender  
[units: participants]
       
Female     2     1     2     5  
Male     9     9     8     26  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     3     2     2     7  
Not Hispanic or Latino     8     8     8     24  
Unknown or Not Reported     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     0     0     0     0  
Asian     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0  
Black or African American     0     0     1     1  
White     11     10     9     30  
More than one race     0     0     0     0  
Unknown or Not Reported     0     0     0     0  
Region of Enrollment  
[units: participants]
       
United States     11     10     10     31  



  Outcome Measures
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1.  Primary:   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 ]

2.  Secondary:   Levels of EGCG in Malignant Bladder Tissue   [ Time Frame: up to 28 days ]

3.  Secondary:   Levels of Surrogate Intermediate Endpoint Biomarkers in Malignant and Nonmalignant Bladder Tissue Assessed by Immunohistochemistry   [ Time Frame: up to 28 days ]

4.  Secondary:   Serum Insulin Growth Factor-1 (IGF-1) Levels Assessed by ELISA   [ Time Frame: Baseline and up to day 28 ]

5.  Secondary:   Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Tumor Tissue Samples   [ Time Frame: up to 28 days ]

6.  Secondary:   Absolute Change for Baseline From EGCG in Serum Samples   [ Time Frame: Baseline and up to 28 days ]

7.  Secondary:   Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Catechol-O-Methyltransferase (COMT)   [ Time Frame: At Baseline ]

8.  Secondary:   Serum IGFBP-3 Levels Assessed by ELISA   [ Time Frame: Baseline and up to 28 days ]

9.  Secondary:   Levels of Other Catechins (Epicatechin Gallate, Epicatechin, and Epigallocatechin) Found in Polyphenon E Normal Tissue Samples   [ Time Frame: up to 28 days ]

10.  Secondary:   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 ]

11.  Secondary:   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 ]

12.  Secondary:   Absolute Change for Baseline of EGCG in Urine Samples   [ Time Frame: Baseline and up to 28 days ]

13.  Secondary:   Metabolism of EGCG in Serum and Urine in Relation to Pharmacogenetic Polymorphisms in Uridinediphosphate- Glucuronosyltransferase (UGT)   [ Time Frame: At Baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Howard H. Bailey
Organization: University of Wisconsin
phone: 608-263-8624
e-mail: hhbailey@wisc.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00666562     History of Changes
Other Study ID Numbers: NCI-2009-00906
NCI-2009-00906 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CO06810
CDR0000594276
H-2007-0250
UWI06-8-01 ( Other Identifier: University of Wisconsin Hospital and Clinics )
UWI06-8-01 ( Other Identifier: DCP )
N01CN35153 ( US NIH Grant/Contract Award Number )
P30CA014520 ( US NIH Grant/Contract Award Number )
Study First Received: April 24, 2008
Results First Received: January 20, 2016
Last Updated: March 28, 2016
Health Authority: United States: Food and Drug Administration