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Pemetrexed Plus Cisplatin Bi-Weekly, in Patients With Urothelial Cancer (Metastatic, Locally Advanced or Non-Resectable)

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00374868
First received: September 11, 2006
Last updated: October 20, 2010
Last verified: October 2010
History of Changes
Results First Received: April 29, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Urologic Neoplasms
Interventions: Drug: pemetrexed
Drug: cisplatin

  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
A total of 59 participants entered the trial (21 in Phase 1 and 38 in Phase 2). Phase 1 determined the dose for Phase 2 to be 400 mg/m^2. Phase 2 results are reported.

Reporting Groups
  Description
Pemetrexed + Cisplatin Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy

Participant Flow:   Overall Study
    Pemetrexed + Cisplatin  
STARTED     38  
COMPLETED     2  
NOT COMPLETED     36  
Adverse Event                 12  
Progressive Disease                 7  
Physician Decision                 13  
Lost to Follow-up                 1  
Death                 2  
Other - Not Specified                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Pemetrexed + Cisplatin Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy

Baseline Measures
    Pemetrexed + Cisplatin  
Number of Participants  
[units: participants]
 		  38  
Age  
[units: years]
Mean ± Standard Deviation 		  67.1  ± 8.7  
Gender  
[units: participants]
 		 
Female     7  
Male     31  
Region of Enrollment  
[units: participants]
 		 
Spain     38  
Eastern Cooperative Oncology Group (ECOG) Performance Status [1]
[units: participants]
 		 
0 - Fully Active     21  
1 - Ambulatory, Restricted Strenuous Activity     15  
2 - Ambulatory, No Work Activities     2  
Location of Primary Tumor  
[units: participants]
 		 
Bladder     32  
Ureter     1  
Urethra     1  
Renal Pelvis     4  
Height  
[units: centimeters]
Mean ± Standard Deviation 		  166  ± 7.5  
Weight  
[units: kilograms]
Mean ± Standard Deviation 		  77.4  ± 13.2  
[1] Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).



  Outcome Measures
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1.  Primary:   Best Overall Tumor Response   [ Time Frame: baseline to measured progressive disease (up to 620 days) ]
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2.  Secondary:   Time to Response   [ Time Frame: baseline to response (up to 620 days) ]
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3.  Secondary:   Duration of Response   [ Time Frame: time of response to progressive disease (up to 620 days) ]
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4.  Secondary:   Duration of Stable Disease   [ Time Frame: time of no response or progression (up to 620 days) ]
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5.  Secondary:   Time to Progressive Disease   [ Time Frame: baseline to measured progressive disease (up to 620 days) ]
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6.  Secondary:   Time to Treatment Failure (TTF)   [ Time Frame: baseline to stopping treatment (up to 620 days) ]
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Measure Type Secondary
Measure Title Time to Treatment Failure (TTF)
Measure Description Time from study enrollment to first observation of disease progression, death from any cause, or early discontinuation of treatment (including toxicity or if patient had stable disease after 4 cycles). TTF was censored at date of last follow-up visit for patients who did not discontinue early, who were still alive, and who had not progressed.
Time Frame baseline to stopping treatment (up to 620 days)  
Safety Issue Yes  

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.
1 patient was censored

Reporting Groups
  Description
Pemetrexed + Cisplatin Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy

Measured Values
    Pemetrexed + Cisplatin  
Number of Participants Analyzed  
[units: participants]
 		  38  
Time to Treatment Failure (TTF)  
[units: days]
Median ( 95% Confidence Interval ) 		  133.5  
  ( 99 to 151 )  

No statistical analysis provided for Time to Treatment Failure (TTF)



7.  Secondary:   Progression-Free Survival   [ Time Frame: baseline to measured progressive disease (up to 620 days) ]
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8.  Secondary:   Overall Survival   [ Time Frame: baseline to date of death from any cause (up to 620 days) ]
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  Serious Adverse Events
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  Other Adverse Events
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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 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.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00374868     History of Changes
Other Study ID Numbers: 8679, H3E-ES-S085
Study First Received: September 11, 2006
Results First Received: April 29, 2009
Last Updated: October 20, 2010
Health Authority: Spain: Ministry of Health
United States: Food and Drug Administration