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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
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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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
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 
Overall Participants Analyzed 
[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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Measure Type Primary
Measure Title Overall Survival (OS)
Measure Description Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.
Time Frame Baseline 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.
Intent-to-treat (ITT) Population: all randomized participants

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 
Participants Analyzed 
[Units: Participants]
 207   209   210 
Overall Survival (OS) 
[Units: Months]
Median (95% Confidence Interval)
 7.3 
 (6.1 to 8.8) 
 10.9 
 (8.6 to 12.7) 
 8.4 
 (6.6 to 10.3) 


Statistical Analysis 1 for Overall Survival (OS)
Groups [1] Interferon Alfa vs. Temsirolimus
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Log Rank
P Value [4] 0.0252
Cox Proportional Hazard [5] 0.78
95% Confidence Interval 0.63 to 0.97
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  2 null hypotheses (Ho) were tested: 1) Survival distributions for temsirolimus alone and Interferon Alfa (IFN)-alone treatment groups were identical. 2) Survival distributions for temsirolimus in combination with IFN and IFN-alone treatment groups were identical. The alternative hypothesis (Ha) for each test was that the survival distributions differed.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Stratified by prior nephrectomy and region
[4] 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.
[5] Other relevant estimation information:
  No text entered.

Statistical Analysis 2 for Overall Survival (OS)
Groups [1] Interferon Alfa vs. Interferon Alfa and Temsirolimus
Non-Inferiority/Equivalence Test [2] Yes
Method [3] Log Rank
P Value [4] 0.4902
Cox Proportional Hazard [5] 0.93
95% Confidence Interval 0.75 to 1.15
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Details of power calculation, definition of non-inferiority margin, and other key parameters:
  2 null hypotheses (Ho) were tested: 1) Survival distributions for temsirolimus alone and IFN-alone treatment groups were identical. 2) Survival distributions for temsirolimus in combination with IFN and IFN-alone treatment groups were identical. The alternative hypothesis (Ha) for each test was that the survival distributions differed.
[3] Other relevant method information, such as adjustments or degrees of freedom:
  Stratified by prior nephrectomy and region
[4] 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.
[5] Other relevant estimation information:
  No text entered.



2.  Secondary:   Progression-Free Survival (PFS)   [ Time Frame: Baseline, monthly until tumor progression or death (up to Month 80) ]

3.  Secondary:   Percentage of Participants With Objective Response   [ Time Frame: Baseline, every 2 months until tumor progression or death (up to Month 80) ]

4.  Secondary:   Percentage of Participants With Clinical Benefit   [ Time Frame: Baseline, every 2 months until tumor progression or death (up to Month 80) ]

5.  Secondary:   Duration of Response (DR)   [ Time Frame: Baseline, every month until tumor progression or death (up to Month 80) ]

6.  Secondary:   Time to Treatment Failure (TTF)   [ Time Frame: Baseline, every month until tumor progression or death (up to Month 80) ]

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

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


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


  More Information