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  
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 ]

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
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Time Frame No text entered.
Additional Description The same event may appear as both an AE and a Serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another subject, or 1 participant may have experienced both a serious and nonserious event during the study.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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

Other Adverse Events
    Interferon Alfa     Temsirolimus     Interferon Alfa and Temsirolimus  
Total, other (not including serious) adverse events        
# participants affected / at risk     197/200     208/208     205/208  
Blood and lymphatic system disorders        
ANEMIA * 1 [3]      
# participants affected / at risk     78/200 (39.00%)     90/208 (43.27%)     123/208 (59.13%)  
THROMBOCYTOPENIA * 1      
# participants affected / at risk     16/200 (8.00%)     28/208 (13.46%)     77/208 (37.02%)  
NEUTROPENIA * 1      
# participants affected / at risk     26/200 (13.00%)     15/208 (7.21%)     57/208 (27.40%)  
LEUKOPENIA * 1      
# participants affected / at risk     34/200 (17.00%)     13/208 (6.25%)     65/208 (31.25%)  
LYMPHOPENIA * 1      
# participants affected / at risk     17/200 (8.50%)     11/208 (5.29%)     28/208 (13.46%)  
Cardiac disorders        
HYPERTENSION * 1 [4]      
# participants affected / at risk     7/200 (3.50%)     12/208 (5.77%)     12/208 (5.77%)  
HYPOTENSION * 1      
# participants affected / at risk     11/200 (5.50%)     10/208 (4.81%)     7/208 (3.37%)  
TACHYCARDIA * 1      
# participants affected / at risk     11/200 (5.50%)     9/208 (4.33%)     17/208 (8.17%)  
VASODILATATION * 1      
# participants affected / at risk     5/200 (2.50%)     5/208 (2.40%)     12/208 (5.77%)  
Gastrointestinal disorders        
NAUSEA * 1 [5]      
# participants affected / at risk     82/200 (41.00%)     76/208 (36.54%)     84/208 (40.38%)  
ANOREXIA * 1      
# participants affected / at risk     86/200 (43.00%)     66/208 (31.73%)     79/208 (37.98%)  
DIARRHEA * 1      
# participants affected / at risk     39/200 (19.50%)     57/208 (27.40%)     56/208 (26.92%)  
CONSTIPATION * 1      
# participants affected / at risk     35/200 (17.50%)     42/208 (20.19%)     39/208 (18.75%)  
STOMATITIS * 1      
# participants affected / at risk     7/200 (3.50%)     41/208 (19.71%)     42/208 (20.19%)  
MUCOSITIS * 1      
# participants affected / at risk     10/200 (5.00%)     39/208 (18.75%)     46/208 (22.12%)  
VOMITING * 1      
# participants affected / at risk     57/200 (28.50%)     39/208 (18.75%)     60/208 (28.85%)  
DRY MOUTH * 1      
# participants affected / at risk     16/200 (8.00%)     13/208 (6.25%)     12/208 (5.77%)  
MOUTH ULCERATION * 1      
# participants affected / at risk     5/200 (2.50%)     6/208 (2.88%)     15/208 (7.21%)  
ORAL MONILIASIS * 1      
# participants affected / at risk     4/200 (2.00%)     5/208 (2.40%)     15/208 (7.21%)  
General disorders        
ASTHENIA * 1 [6]      
# participants affected / at risk     126/200 (63.00%)     105/208 (50.48%)     127/208 (61.06%)  
PAIN * 1      
# participants affected / at risk     30/200 (15.00%)     56/208 (26.92%)     41/208 (19.71%)  
FEVER * 1      
# participants affected / at risk     98/200 (49.00%)     49/208 (23.56%)     126/208 (60.58%)  
ABDOMINAL PAIN * 1      
# participants affected / at risk     34/200 (17.00%)     42/208 (20.19%)     34/208 (16.35%)  
BACK PAIN * 1      
# participants affected / at risk     28/200 (14.00%)     41/208 (19.71%)     31/208 (14.90%)  
CHEST PAIN * 1      
# participants affected / at risk     18/200 (9.00%)     35/208 (16.83%)     23/208 (11.06%)  
HEADACHE * 1      
# participants affected / at risk     30/200 (15.00%)     32/208 (15.38%)     47/208 (22.60%)  
INFECTION * 1      
# participants affected / at risk     11/200 (5.50%)     29/208 (13.94%)     32/208 (15.38%)  
ALLERGIC REACTION * 1      
# participants affected / at risk     1/200 (0.50%)     18/208 (8.65%)     11/208 (5.29%)  
CHILLS * 1      
# participants affected / at risk     58/200 (29.00%)     17/208 (8.17%)     72/208 (34.62%)  
FACE EDEMA * 1      
# participants affected / at risk     1/200 (0.50%)     15/208 (7.21%)     10/208 (4.81%)  
ACCIDENTAL INJURY * 1      
# participants affected / at risk     8/200 (4.00%)     13/208 (6.25%)     12/208 (5.77%)  
FLU SYNDROME * 1      
# participants affected / at risk     23/200 (11.50%)     8/208 (3.85%)     28/208 (13.46%)  
LAB TEST ABNORMAL * 1      
# participants affected / at risk     5/200 (2.50%)     8/208 (3.85%)     13/208 (6.25%)  
TASTE PERVERSION * 1 [7]      
# participants affected / at risk     13/200 (6.50%)     31/208 (14.90%)     18/208 (8.65%)  
TASTE LOSS * 1 [7]      
# participants affected / at risk     4/200 (2.00%)     11/208 (5.29%)     5/208 (2.40%)  
Metabolism and nutrition disorders        
HYPERLIPEMIA * 1 [8]      
# participants affected / at risk     29/200 (14.50%)     57/208 (27.40%)     80/208 (38.46%)  
PERIPHERAL EDEMA * 1      
# participants affected / at risk     15/200 (7.50%)     54/208 (25.96%)     36/208 (17.31%)  
HYPERCHOLESTEREMIA * 1      
# participants affected / at risk     9/200 (4.50%)     51/208 (24.52%)     55/208 (26.44%)  
HYPERGLYCEMIA * 1      
# participants affected / at risk     22/200 (11.00%)     49/208 (23.56%)     36/208 (17.31%)  
WEIGHT LOSS * 1      
# participants affected / at risk     49/200 (24.50%)     40/208 (19.23%)     65/208 (31.25%)  
CREATININE INCREASED * 1      
# participants affected / at risk     21/200 (10.50%)     28/208 (13.46%)     42/208 (20.19%)  
ALKALINE PHOSPHATASE INCREASED * 1      
# participants affected / at risk     15/200 (7.50%)     20/208 (9.62%)     31/208 (14.90%)  
HYPOKALEMIA * 1      
# participants affected / at risk     7/200 (3.50%)     20/208 (9.62%)     14/208 (6.73%)  
EDEMA * 1      
# participants affected / at risk     8/200 (4.00%)     19/208 (9.13%)     8/208 (3.85%)  
HYPOPHOSPHATEMIA * 1      
# participants affected / at risk     4/200 (2.00%)     17/208 (8.17%)     21/208 (10.10%)  
SGOT INCREASED * 1      
# participants affected / at risk     29/200 (14.50%)     16/208 (7.69%)     43/208 (20.67%)  
HYPOPROTEINEMIA * 1      
# participants affected / at risk     18/200 (9.00%)     13/208 (6.25%)     21/208 (10.10%)  
LACTIC DEHYDROGENASE INCREASED * 1      
# participants affected / at risk     7/200 (3.50%)     12/208 (5.77%)     19/208 (9.13%)  
SGPT INCREASED * 1      
# participants affected / at risk     14/200 (7.00%)     12/208 (5.77%)     15/208 (7.21%)  
HYPOCALCEMIA * 1      
# participants affected / at risk     21/200 (10.50%)     11/208 (5.29%)     32/208 (15.38%)  
HYPERCALCEMIA * 1      
# participants affected / at risk     11/200 (5.50%)     8/208 (3.85%)     8/208 (3.85%)  
HYPERKALEMIA * 1      
# participants affected / at risk     18/200 (9.00%)     8/208 (3.85%)     11/208 (5.29%)  
DEHYDRATION * 1      
# participants affected / at risk     15/200 (7.50%)     7/208 (3.37%)     22/208 (10.58%)  
HYPONATREMIA * 1      
# participants affected / at risk     7/200 (3.50%)     6/208 (2.88%)     15/208 (7.21%)  
BUN INCREASED * 1      
# participants affected / at risk     5/200 (2.50%)     3/208 (1.44%)     11/208 (5.29%)  
Musculoskeletal and connective tissue disorders        
ARTHRALGIA * 1 [9]      
# participants affected / at risk     29/200 (14.50%)     38/208 (18.27%)     27/208 (12.98%)  
MYALGIA * 1      
# participants affected / at risk     30/200 (15.00%)     16/208 (7.69%)     22/208 (10.58%)  
BONE PAIN * 1      
# participants affected / at risk     11/200 (5.50%)     8/208 (3.85%)     7/208 (3.37%)  
Nervous system disorders        
INSOMNIA * 1 [10]      
# participants affected / at risk     29/200 (14.50%)     25/208 (12.02%)     36/208 (17.31%)  
DIZZINESS * 1      
# participants affected / at risk     25/200 (12.50%)     18/208 (8.65%)     27/208 (12.98%)  
ANXIETY * 1      
# participants affected / at risk     12/200 (6.00%)     16/208 (7.69%)     24/208 (11.54%)  
PARESTHESIA * 1      
# participants affected / at risk     10/200 (5.00%)     14/208 (6.73%)     13/208 (6.25%)  
SOMNOLENCE * 1      
# participants affected / at risk     21/200 (10.50%)     14/208 (6.73%)     14/208 (6.73%)  
DEPRESSION * 1      
# participants affected / at risk     26/200 (13.00%)     9/208 (4.33%)     25/208 (12.02%)  
CONFUSION * 1      
# participants affected / at risk     17/200 (8.50%)     6/208 (2.88%)     10/208 (4.81%)  
Renal and urinary disorders        
URINARY TRACT INFECTION * 1 [11]      
# participants affected / at risk     10/200 (5.00%)     16/208 (7.69%)     23/208 (11.06%)  
Respiratory, thoracic and mediastinal disorders        
DYSPNEA * 1 [12]      
# participants affected / at risk     42/200 (21.00%)     59/208 (28.37%)     51/208 (24.52%)  
COUGH INCREASED * 1      
# participants affected / at risk     29/200 (14.50%)     55/208 (26.44%)     49/208 (23.56%)  
EPISTAXIS * 1      
# participants affected / at risk     7/200 (3.50%)     27/208 (12.98%)     27/208 (12.98%)  
PHARYNGITIS * 1      
# participants affected / at risk     3/200 (1.50%)     24/208 (11.54%)     27/208 (12.98%)  
RHINITIS * 1      
# participants affected / at risk     4/200 (2.00%)     20/208 (9.62%)     10/208 (4.81%)  
UPPER RESPIRATORY INFECTION * 1      
# participants affected / at risk     1/200 (0.50%)     14/208 (6.73%)     7/208 (3.37%)  
Skin and subcutaneous tissue disorders        
RASH * 1 [13]      
# participants affected / at risk     11/200 (5.50%)     76/208 (36.54%)     34/208 (16.35%)  
PRURITUS * 1      
# participants affected / at risk     16/200 (8.00%)     40/208 (19.23%)     24/208 (11.54%)  
NAIL DISORDER * 1      
# participants affected / at risk     1/200 (0.50%)     28/208 (13.46%)     5/208 (2.40%)  
DRY SKIN * 1      
# participants affected / at risk     14/200 (7.00%)     22/208 (10.58%)     13/208 (6.25%)  
ACNE * 1      
# participants affected / at risk     2/200 (1.00%)     21/208 (10.10%)     7/208 (3.37%)  
EXFOLIATIVE DERMATITIS * 1      
# participants affected / at risk     1/200 (0.50%)     16/208 (7.69%)     6/208 (2.88%)  
PRURITIC RASH * 1      
# participants affected / at risk     1/200 (0.50%)     11/208 (5.29%)     3/208 (1.44%)  
SKIN DISORDER * 1      
# participants affected / at risk     1/200 (0.50%)     11/208 (5.29%)     6/208 (2.88%)  
SWEATING * 1      
# participants affected / at risk     14/200 (7.00%)     5/208 (2.40%)     15/208 (7.21%)  
* Events were collected by non-systematic assessment
1 Term from vocabulary, COSTART
[3] Hemic and Lymphatic system
[4] Cardiovascular system
[5] Digestive system
[6] Body as a whole
[7] Special Senses
[8] Metabolic and Nutritional
[9] Musculoskeletal system
[10] Nervous system
[11] Urogenital system
[12] Respiratory system
[13] Skin and Appendages



  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.


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