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Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma (ARCC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00065468
First received: July 24, 2003
Last updated: September 24, 2012
Last verified: September 2012
History of Changes
Results First Received: March 22, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Carcinoma, Renal Cell
Kidney Neoplasms
Interventions: Drug: Interferon Alfa
Drug: CCI-779
Drug: Interferon Alfa and CCI-779

  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
No text entered.

Reporting Groups
  Description
Interferon Alfa Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
Temsirolimus Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
Interferon Alfa and Temsirolimus Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal

Participant Flow:   Overall Study
    Interferon Alfa     Temsirolimus     Interferon Alfa and Temsirolimus  
STARTED     207     209     210  
Received Treatment     200     208     208  
COMPLETED     0     0     0  
NOT COMPLETED     207     209     210  
Death                 172                 169                 171  
Withdrawal by Subject                 3                 4                 5  
Lost to Follow-up                 5                 3                 2  
Discontinuation of study by Sponsor                 13                 9                 13  
Disease progression                 0                 0                 1  
Unspecified                 14                 24                 18  



  Baseline Characteristics
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Reporting Groups
  Description
Interferon Alfa Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
Temsirolimus Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
Interferon Alfa and Temsirolimus Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
Total Total of all reporting groups

Baseline Measures
    Interferon Alfa     Temsirolimus     Interferon Alfa and Temsirolimus     Total  
Number of Participants  
[units: participants]
 		  207     209     210     626  
Age  
[units: years]
Mean ± Standard Deviation 		  59.2  ± 10.4     58.7  ± 10.0     59.3  ± 9.8     59.1  ± 10.1  
Gender  
[units: participants]
 		       
Female     59     70     65     194  
Male     148     139     145     432  



  Outcome Measures
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1.  Primary:   Overall Survival (OS)   [ Time Frame: Baseline up to Month 80 ]
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2.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Baseline, monthly until tumor progression or death (up to Month 80) ]
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3.  Secondary:   Percentage of Participants With Objective Response   [ Time Frame: Baseline, every 2 months until tumor progression or death (up to Month 80) ]
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4.  Secondary:   Percentage of Participants With Clinical Benefit   [ Time Frame: Baseline, every 2 months until tumor progression or death (up to Month 80) ]
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5.  Secondary:   Duration of Response (DR)   [ Time Frame: Baseline, every month until tumor progression or death (up to Month 80) ]
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6.  Secondary:   Time to Treatment Failure (TTF)   [ Time Frame: Baseline, every month until tumor progression or death (up to Month 80) ]
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Measure Type Secondary
Measure Title Time to Treatment Failure (TTF)
Measure Description TTF is defined as the time from the date of randomization to the date of PD or death, withdrawal from treatment due to an adverse event (AE), withdrawal of voluntary consent, or lost to follow-up, whichever occurred first, censored at the date of the conclusion of treatment phase.
Time Frame Baseline, every month until tumor progression or death (up to Month 80)  
Safety Issue No  

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.
ITT

Reporting Groups
  Description
Interferon Alfa Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
Temsirolimus Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
Interferon Alfa and Temsirolimus Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal

Measured Values
    Interferon Alfa     Temsirolimus     Interferon Alfa and Temsirolimus  
Number of Participants Analyzed  
[units: participants]
 		  207     209     210  
Time to Treatment Failure (TTF)  
[units: months]
Median ( 95% Confidence Interval ) 		  1.9  
  ( 1.7 to 1.9 )   		  3.7  
  ( 3.4 to 3.9 )   		  2.5  
  ( 1.9 to 3.6 )  


Statistical Analysis 1 for Time to Treatment Failure (TTF)
Groups [1] Interferon Alfa vs. Temsirolimus
Method [2] Log Rank
P Value [3] <0.0001
Cox Proportional Hazard [4] 0.62
95% Confidence Interval ( 0.51 to 0.76 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  Stratified by prior nephrectomy and region
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Time to Treatment Failure (TTF)
Groups [1] Interferon Alfa vs. Interferon Alfa and Temsirolimus
Method [2] Log Rank
P Value [3] 0.0020
Cox Proportional Hazard [4] 0.73
95% Confidence Interval ( 0.60 to 0.89 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  Stratified by prior nephrectomy and region
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



7.  Secondary:   Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST)   [ Time Frame: Baseline to Month 80 ]
  Show Outcome Measure 7

8.  Secondary:   European Quality of Life Health Questionnaire (EQ-5D) - Index Score   [ Time Frame: Baseline ]
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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 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.


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
Efficacy data was not collected or analyzed after the primary analysis was completed.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided by Pfizer

Publications automatically indexed to this study:


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00065468     History of Changes
Obsolete Identifiers: NCT00070330
Other Study ID Numbers: 3066K1-304
Study First Received: July 24, 2003
Results First Received: March 22, 2012
Last Updated: September 24, 2012
Health Authority: United States: Food and Drug Administration