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Instillation of Gemcitabine in Patients With Superficial Bladder Cancer

This study has been terminated.
(The study was stopped early for futility reasons.)
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191477
First received: September 12, 2005
Last updated: September 24, 2009
Last verified: September 2009
Results First Received: March 17, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Bladder Neoplasms
Interventions: Drug: Gemcitabine
Drug: Placebo

  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
355 participants were enrolled and randomized (included here in disposition); however, due to study design, only 328 (N=166 Gemcitabine and N=162 Placebo) actually received study drug (Full Analysis Set).

Reporting Groups
  Description
Gemcitabine Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
Placebo Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)

Participant Flow:   Overall Study
    Gemcitabine   Placebo
STARTED   179   176 
Received Study Drug   166   162 
COMPLETED   41   47 
NOT COMPLETED   138   129 
Tumor Recurrence                49                48 
Death, Study Disease                1                1 
Death, Other Cause                3                6 
Lost to Follow-up                23                21 
Protocol Violation                1                1 
Treatment Change                2                0 
Withdrawal by Subject                2                0 
Unspecified                2                0 
Not Eligible                41                38 
Pathological Specimen Lost                1                0 
Discontinued Prior to Instillation                13                14 



  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
Gemcitabine Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
Placebo Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
Total Total of all reporting groups

Baseline Measures
   Gemcitabine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 166   162   328 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.2  (11.9)   66.3  (11.0)   64.7  (11.5) 
Gender 
[Units: Participants]
     
Female   39   26   65 
Male   127   136   263 
Region of Enrollment 
[Units: Participants]
     
Germany   131   126   257 
Turkey   35   36   71 
Karnofsky Performance Status [1] 
[Units: Participants]
     
70 - Unable to carry on normal activity   1   1   2 
80 - Activity with effort; some signs of disease   13   7   20 
90 - Normal activity; minor signs of disease   33   49   82 
100 - Normal no complaints; no evidence of disease   118   104   222 
Unspecified   1   1   2 
[1] Classifies patients according to their functional impairment. Rating occurs in steps of 10 score points (0=death, 10, 20,....up to 100=Normal no complaints, no evidence of disease). Lower scores indicate poorer patient condition.
Newly Diagnosed versus Recurrent Disease 
[Units: Participants]
     
Recurrent Disease   43   40   83 
Newly Diagnosed   123   122   245 
Race/Ethnicity 
[Units: Participants]
     
White   166   162   328 
Results of Initial Transurethral Resection of a Bladder Tumor (TUR-BT): Number of Visible Lesions [1] 
[Units: Participants]
     
No Lesions (No Specific Sites Documented)   4   5   9 
1 Lesion   87   96   183 
2 Lesions   42   27   69 
3 Lesions   18   14   32 
4 Lesions   7   10   17 
>=5 Lesions   8   10   18 
[1] The initial TUR-BT was the first and mandatory TUR-BT during the study. An optional second TUR-BT was allowed.
Results of Transurethral Resection of Bladder Tumor (TUR-BT): Final Pathological Disease Stage [1] 
[Units: Participants]
     
pTx: Primary Tumor Cannot be Assessed   3   0   3 
pT0: No Evidence of Primary Tumor   0   0   0 
pTa: Noninvasive Papillary Carcinoma   93   88   181 
pT1: Tumor Invades Subepithelial Connective Tissue   31   36   67 
>=pT2: Tumor Invades Wider Area   12   10   22 
Cis: Carcinoma in situ ("Flat Tumor")   5   6   11 
No Malignancy   21   22   43 
Unspecified   1   0   1 
[1] Worst staging of the initial and optional second transurethral resection of bladder tumor.
Results of Transurethral Resection on a Bladder Tumor (TUR-BT): Final Disease Grade [1] 
[Units: Participants]
     
G1 - Well Differentiated   59   66   125 
G2 - Moderately Differentiated   50   48   98 
G3 - Poorly Differentiated   25   24   49 
G4 - Undifferentiated   3   1   4 
GX - Unknown   8   1   9 
Unspecified   21   22   43 
[1] Worst grading of the initial and optional second transurethral resection of bladder tumor.


  Outcome Measures
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1.  Primary:   Recurrence-Free Survival (RFS)   [ Time Frame: Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) ]

2.  Secondary:   Time to Recurrence   [ Time Frame: Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) ]

3.  Secondary:   Recurrence-Free Survival (RFS) in Subgroups   [ Time Frame: Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) ]

4.  Secondary:   Tumor Recurrence Type   [ Time Frame: Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) ]

5.  Post-Hoc:   Percentage of Participants Without Tumor Recurrence   [ Time Frame: Surgery to recurrence (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) ]

6.  Post-Hoc:   Percentage of Participants in Subgroups With Recurrence-Free Survival (RFS) at 12 and 24 Months   [ Time Frame: Surgery to recurrence or death (Follow-up assessments were performed at 3 and 6 months after the first TUR-BT, and every 6 months thereafter, until recurrence/progression of disease, or until the end of study, up to 24 months) ]


  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
The study was stopped early for futility reasons. In addition, due to limitations in this databank, some original outcome measures are not disclosed. Time to Recurrence and Recurrence-Free Survival in Subgroups had data that were un-estimated.


  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 less than or equal to 60 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: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-800-545-5979


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

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00191477     History of Changes
Other Study ID Numbers: 6138
B9E-MC-S274
Study First Received: September 12, 2005
Results First Received: March 17, 2009
Last Updated: September 24, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices