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  
Number of Participants  
[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  
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 [2]
[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  
Results of Transurethral Resection of Bladder Tumor (TUR-BT): Final Pathological Disease Stage [3]
[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  
Results of Transurethral Resection on a Bladder Tumor (TUR-BT): Final Disease Grade [4]
[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] 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.
[2] The initial TUR-BT was the first and mandatory TUR-BT during the study. An optional second TUR-BT was allowed.
[3] Worst staging of the initial and optional second transurethral resection of bladder tumor.
[4] 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


No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:

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