Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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 ]

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 (98.50%)   208/208 (100.00%)   205/208 (98.56%) 
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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