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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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  
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 ]

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  
Number of 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) ]

Measure Type Secondary
Measure Title Progression-Free Survival (PFS)
Measure Description PFS based on Independent Central Review Assessment. The period from randomization until disease progression, death or date of last contact.
Time Frame Baseline, monthly 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  
Progression-Free Survival (PFS)  
[units: months]
Median ( 95% Confidence Interval )
  3.2  
  ( 2.2 to 4.0 )  
  5.6  
  ( 3.9 to 7.2 )  
  4.9  
  ( 3.9 to 6.0 )  


Statistical Analysis 1 for Progression-Free Survival (PFS)
Groups [1] Interferon Alfa vs. Temsirolimus
Method [2] Log Rank
P Value [3] 0.0042
Cox Proportional Hazard [4] 0.74
95% Confidence Interval ( 0.60 to 0.91 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method 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 Progression-Free Survival (PFS)
Groups [1] Interferon Alfa vs. Interferon Alfa and Temsirolimus
Method [2] Log Rank
P Value [3] 0.0107
Cox Proportional Hazard [4] 0.76
95% Confidence Interval ( 0.62 to 0.94 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method 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.



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

Measure Type Secondary
Measure Title Percentage of Participants With Objective Response
Measure Description Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was the disappearance of all target lesions and non target lesions. PR was at least a 30 percent (%) decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
Time Frame Baseline, every 2 months 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  
Percentage of Participants With Objective Response  
[units: percentage of participants]
Number ( 95% Confidence Interval )
  5.3  
  ( 2.3 to 8.4 )  
  9.1  
  ( 5.2 to 13.0 )  
  9.5  
  ( 5.6 to 13.5 )  


Statistical Analysis 1 for Percentage of Participants With Objective Response
Groups [1] Interferon Alfa vs. Temsirolimus
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.1361
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method 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.

Statistical Analysis 2 for Percentage of Participants With Objective Response
Groups [1] Interferon Alfa vs. Interferon Alfa and Temsirolimus
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.1062
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method 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.  Secondary:   Percentage of Participants With Clinical Benefit   [ Time Frame: Baseline, every 2 months until tumor progression or death (up to Month 80) ]

Measure Type Secondary
Measure Title Percentage of Participants With Clinical Benefit
Measure Description Clinical benefit: confirmed CR or PR or had stable disease (SD) lasting at least 24 weeks. CR was the disappearance of all target lesions and non target lesions. PR was at least a 30% decrease in sum of the LD of target lesions, taking as reference the baseline sum LD. SD was having neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Time Frame Baseline, every 2 months 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  
Percentage of Participants With Clinical Benefit  
[units: percentage of participants]
Number ( 95% Confidence Interval )
  16.4  
  ( 11.4 to 21.5 )  
  34.0  
  ( 27.6 to 40.4 )  
  30.0  
  ( 23.8 to 36.2 )  


Statistical Analysis 1 for Percentage of Participants With Clinical Benefit
Groups [1] Interferon Alfa vs. Temsirolimus
Method [2] Cochran-Mantel-Haenszel
P Value [3] <0.0001
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method 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.

Statistical Analysis 2 for Percentage of Participants With Clinical Benefit
Groups [1] Interferon Alfa vs. Interferon Alfa and Temsirolimus
Method [2] Cochran-Mantel-Haenszel
P Value [3] 0.0011
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant method 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.



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

Measure Type Secondary
Measure Title Duration of Response (DR)
Measure Description DR: Time from first documentation of objective tumor response to first date that recurrence or progressive disease (PD) was objectively documented, taking as a reference for PD, the smallest sum LD recorded since randomization.
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 subset of participants who had a response

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]
  11     19     20  
Duration of Response (DR)  
[units: months]
Median ( 95% Confidence Interval )
  7.4  
  ( 5.1 to 18.4 )  
  11.1  
  ( 9.1 to 13.8 )  
  9.3  
  ( 5.8 to 23.1 )  

No statistical analysis provided for Duration of Response (DR)



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

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 method 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 method 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 ]

Measure Type Secondary
Measure Title Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST)
Measure Description The Q-Twist is not a score calculated for each participant but is defined only on a by treatment group basis. For each treatment group, it is the weighted sum of the mean durations of the health states Tox, Twist, and Relapse. Tox is defined as time with severe toxicity related to treatment; Twist: time without symptoms or toxic side effects; and Relapse: time after relapse/progression. The mean duration of each health state is calculated based on the area under the Kaplan Meier curve pertaining to that health state. There is no direct method for calculating the “dispersion” of Q-Twist, and it is typically done using bootstrap method for purposes of inference (see, e.g., Glasziou PP, Simes RJ, Gelber RD. Quality adjusted survival analysis. Stat Med 1990; 9: 1259-76). In practice, as apparently in the case with this study, the intermediate values resulting from the bootstrap exercise were not displayed.
Time Frame Baseline to Month 80  
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.
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  
Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST)  
[units: months]
  6.9083     8.3707     7.4821  

No statistical analysis provided for Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST)



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

Measure Type Secondary
Measure Title European Quality of Life Health Questionnaire (EQ-5D) - Index Score
Measure Description EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. EQ-5D index measured 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Range of EQ-5D index score = -0.594 to 1 where higher scores indicated a better health state.
Time Frame Baseline  
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;(N)=participants with evaluable data. Week 12 and 32 data collected for individual participants but not summarized.

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]
  197     204     197  
European Quality of Life Health Questionnaire (EQ-5D) - Index Score  
[units: units on a scale]
Median ( Full Range )
  0.656  
  ( -0.319 to 1.000 )  
  0.689  
  ( -0.181 to 1.000 )  
  0.689  
  ( -0.239 to 1.000 )  

No statistical analysis provided for European Quality of Life Health Questionnaire (EQ-5D) - Index Score




  Serious Adverse Events


  Other Adverse Events


  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