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Phase II Study of Isoflavone G-2535 (Genistein) in Patients With Bladder Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00118040
First received: July 8, 2005
Last updated: February 23, 2016
Last verified: February 2013
Results First Received: December 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Recurrent Bladder Cancer
Stage I Bladder Cancer
Stage II Bladder Cancer
Stage III Bladder Cancer
Interventions: Drug: genistein
Other: laboratory biomarker analysis
Other: placebo
Procedure: therapeutic conventional surgery
Other: pharmacological study

  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 3 year period by staff at 7 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 (300mg Genistein) Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
Arm II (600mg Genistein) Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
Arm III (Placebo) Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.

Participant Flow:   Overall Study
    Arm I (300mg Genistein)   Arm II (600mg Genistein)   Arm III (Placebo)
STARTED   20   20   20 
COMPLETED   19   18   14 
NOT COMPLETED   1   2   6 
Adverse Event                0                1                0 
Withdrawal by Subject                0                0                2 
Medical Contraindication                0                0                1 
Non-Compliant Participant                1                1                2 
Other                0                0                1 



  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 (300mg Genistein) Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
Arm II (600mg Genistein) Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
Arm III (Placebo) Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
Total Total of all reporting groups

Baseline Measures
   Arm I (300mg Genistein)   Arm II (600mg Genistein)   Arm III (Placebo)   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   20   60 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   8   7   7   22 
>=65 years   12   13   13   38 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.60  (9.16)   68.65  (9.16)   71.95  (12.67)   69.73  (10.40) 
Gender 
[Units: Participants]
       
Female   5   1   2   8 
Male   15   19   18   52 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   0   0   0   0 
Not Hispanic or Latino   20   20   20   60 
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   0   0 
White   20   20   20   60 
More than one race   0   0   0   0 
Unknown or Not Reported   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
United States   20   20   20   60 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Epidermal Growth Factor Receptor (EGFR) Phosphorylation in Tumor Tissue, as Measured by Immunohistochemistry After the Completion of Treatment   [ Time Frame: up to 21 days ]

2.  Primary:   pEGFR in Benign Tissue   [ Time Frame: up to 21 days on Study Drug ]

3.  Secondary:   BLCA-4 in Urine by Visit   [ Time Frame: up to 21 days ]

4.  Secondary:   Survivin in Urine by Visit (pg/ml)   [ Time Frame: up to 21 days ]

5.  Secondary:   Survivin in Tumor Tissue   [ Time Frame: up to 21 days on Study Drug ]

6.  Secondary:   EGFR Mutations in Tumor Tissue   [ Time Frame: up to 21 days on Study Drug ]

7.  Secondary:   EGFR in Benign Tissue   [ Time Frame: up to 21 days on Study Drug ]

8.  Secondary:   Ki-67 in Tumor Tissue   [ Time Frame: up to 21 days on Study Drug ]

9.  Secondary:   Activated Caspase 3 in Tumor Tissue   [ Time Frame: up to 21 days on Study Drug ]

10.  Secondary:   COX2 in Tumor Tissue   [ Time Frame: up to 21 days on Study Drug ]

11.  Secondary:   AKT in Tumor Tissue   [ Time Frame: up to 21 days on Study Drug ]

12.  Secondary:   pAKT in Tumor Tissue   [ Time Frame: up to 21 days on Study Drug ]

13.  Secondary:   MAP Kinase in Tumor Tissue   [ Time Frame: up to 21 days on Study Drug ]

14.  Secondary:   pMAP Kinase in Tumor Tissue   [ Time Frame: up to 21 days on Study Drug ]


  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
No text entered.


  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, M.D.
Organization: University of Wisconsin
phone: 608-263-8624
e-mail: hhbailey@wisc.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00118040     History of Changes
Other Study ID Numbers: NCI-2013-00453
NCI-2013-00453 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000433520
WCCC-UWI03-1-01
WCCC-H-2005-0026
WCCC-CO-04307
UWI03-1-01 ( Other Identifier: University of Wisconsin Chemoprevention Consortium )
UWI03-1-01 ( Other Identifier: DCP )
N01CN35153 ( US NIH Grant/Contract Award Number )
Study First Received: July 8, 2005
Results First Received: December 10, 2015
Last Updated: February 23, 2016
Health Authority: United States: Food and Drug Administration