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S0353, Gemcitabine in Treating Patients With Recurrent Bladder Cancer That Has Not Responded to Previous Bacillus Calmette-Guerin

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00234039
First received: October 5, 2005
Last updated: June 11, 2014
Last verified: June 2014
Results First Received: November 19, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Bladder Cancer
Intervention: Drug: gemcitabine hydrochloride

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intravesical Gemcitabine Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.

Participant Flow:   Overall Study
    Intravesical Gemcitabine  
STARTED     58  
Eligible     49  
Eligible and Began Protocol Therapy     47  
COMPLETED     8  
NOT COMPLETED     50  
Adverse Event                 2  
Progression/relapse                 34  
Other - Not Protocol Specified                 3  
Ineligible                 9  
No Protocol Treatment Received                 2  



  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.
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Reporting Groups
  Description
Intravesical Gemcitabine Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.

Baseline Measures
    Intravesical Gemcitabine  
Number of Participants  
[units: participants]
  47  
Age  
[units: years]
Median ( Full Range )
  70  
  ( 50 to 88 )  
Gender  
[units: participants]
 
Female     14  
Male     33  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     0  
Not Hispanic or Latino     45  
Unknown or Not Reported     2  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     3  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     0  
White     43  
More than one race     1  
Unknown or Not Reported     0  



  Outcome Measures
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1.  Primary:   Complete Response Rate at the End of Induction   [ Time Frame: Week 8-12, then every 3 months for the first 2 years, and then every 6 months for the years 3-5 ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: 1 year ]

3.  Secondary:   Recurrence-free Survival (RFS)   [ Time Frame: 1 year ]

4.  Secondary:   Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug   [ Time Frame: Patients were assessed for adverse events weekly for 6 weeks and then every 4 weeks for 40 weeks ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Study Statistician
Organization: SWOG Statistical Center
phone: 206-667-4623


No publications provided


Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00234039     History of Changes
Other Study ID Numbers: CDR0000446074, U10CA032102, S0353
Study First Received: October 5, 2005
Results First Received: November 19, 2012
Last Updated: June 11, 2014
Health Authority: United States: Federal Government