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Trial record 23 of 640 for:    Russian Federation | Chile

Study Comparing Bevacizumab + Temsirolimus vs. Bevacizumab + Interferon-Alfa In Advanced Renal Cell Carcinoma Subjects (INTORACT)

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ClinicalTrials.gov Identifier: NCT00631371
Recruitment Status : Completed
First Posted : March 7, 2008
Results First Posted : June 4, 2013
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Renal Cell Carcinoma
Interventions Drug: Bevacizumab
Drug: Temsirolimus
Drug: Interferon-Alfa 9MU
Enrollment 791
Recruitment Details Approximately 800 participants enrolled in this study at 200 sites.
Pre-assignment Details Participants were randomized in a 1:1 ratio, stratified by prior nephrectomy status (yes/no) and Memorial Sloan Kettering Cancer Center (MSKCC) risk factors (good/intermediate/poor), and received either the combination treatment of Temisirolimus + Bevacizumab (Temsr+Bev) or Interferon-alfa + Bevacizumab (IFN+Bev).
Arm/Group Title Bevacizumab+Temsirolimus Bevacizumab+ Interferon-Alfa
Hide Arm/Group Description Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death. Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
Period Title: Overall Study
Started 400 391
Treated 393 391
Completed 0 0
Not Completed 400 391
Reason Not Completed
Lost to Follow-up             24             19
Other reason             5             12
subject request             38             45
Discontinuation of study by Sponsor             70             76
Death             263             239
Arm/Group Title Bevacizumab+Temsirolimus Bevacizumab+ Interferon-Alfa Total
Hide Arm/Group Description Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death. Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death. Total of all reporting groups
Overall Number of Baseline Participants 400 391 791
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 400 participants 391 participants 791 participants
58.6  (10.1) 58.2  (10.4) 58.4  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 400 participants 391 participants 791 participants
Female
114
  28.5%
121
  30.9%
235
  29.7%
Male
286
  71.5%
270
  69.1%
556
  70.3%
1.Primary Outcome
Title Progression-Free Survival (PFS): Independent-Assessment
Hide Description PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by independent imaging reviewers using Response Evaluation Criteria in Solid Tumors (RECIST) criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.
Time Frame Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all participants who were randomized to the study.
Arm/Group Title Bevacizumab+Temsirolimus Bevacizumab+ Interferon-Alfa
Hide Arm/Group Description:
Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
Overall Number of Participants Analyzed 400 391
Median (95% Confidence Interval)
Unit of Measure: months
9.1
(8.1 to 10.2)
9.3
(9.0 to 11.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bevacizumab+Temsirolimus, Bevacizumab+ Interferon-Alfa
Comments P value was based on 1-sided stratified log-rank test (stratification factors: prior nephrectomy [yes/no] and Memorial Sloan Kettering Cancer Center [MSKCC] risk factors [good/intermediate/poor] at time of randomization). The hazard ratio and corresponding 95 percent (%) confidence interval (CI) from the stratified cox proportional hazard model were also presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
0.9 to 1.3
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Progression-Free Survival (PFS): Investigator-Assessment
Hide Description PFS was defined as the interval from the date of randomization until the earlier date of progression or death. Progression was assessed by investigator imaging reviewers using RECIST criteria which is 20% increase in sum of longest diameter of target lesions from nadir (the lowest blood counts); measurable increase in non-target lesion; appearance of new lesions.
Time Frame Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study.
Arm/Group Title Bevacizumab+Temsirolimus Bevacizumab+ Interferon-Alfa
Hide Arm/Group Description:
Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
Overall Number of Participants Analyzed 400 391
Median (95% Confidence Interval)
Unit of Measure: months
9.1
(8.1 to 10.5)
10.8
(9.1 to 11.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bevacizumab+Temsirolimus, Bevacizumab+ Interferon-Alfa
Comments P-value was based on 1-sided stratified log-rank test (stratification factors: prior nephrectomy [yes/no] and MSKCC risk factors [good/intermediate/poor] at time of randomization). The hazard ratio and corresponding 95% CI from the stratified cox proportional hazard model were also presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.1
Confidence Interval (2-Sided) 95%
1.0 to 1.4
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Percentage of Participants With Objective Response (Complete Response/Partial Response): Independent-Assessment
Hide Description Percentage of participants with OR based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to RECIST. Confirmed response were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as disappearance of all lesions (target and/or non target). PR were those with at least 30% decrease in sum of the longest dimensions of target lesions taking as a reference the baseline sum longest dimensions, with non target lesions not increased or absent.
Time Frame Baseline until disease progression, initiation of new anticancer treatment, or death, assessed every 8 weeks (up to cut-off date: 19 April 2012)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study.
Arm/Group Title Bevacizumab+Temsirolimus Bevacizumab+ Interferon-Alfa
Hide Arm/Group Description:
Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
Overall Number of Participants Analyzed 400 391
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
27.0
(22.7 to 31.6)
27.4
(23.0 to 32.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bevacizumab+Temsirolimus, Bevacizumab+ Interferon-Alfa
Comments P-value (2-sided), risk ratio and associated 95% CI were based on Cochran-Mantel-Haenszel test stratified by prior nephrectomy and MSKCC risk group as randomized.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.8 to 1.3
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS was defined as the time from randomization to death due to any cause, censored at the last date known alive. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Time Frame Baseline until death due to any cause, assessed every 8 weeks (up to cut-off date: 19 April 2012)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were randomized to the study.
Arm/Group Title Bevacizumab+Temsirolimus Bevacizumab+ Interferon-Alfa
Hide Arm/Group Description:
Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
Overall Number of Participants Analyzed 400 391
Median (95% Confidence Interval)
Unit of Measure: months
25.8
(21.1 to 30.7)
25.5
(22.4 to 30.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bevacizumab+Temsirolimus, Bevacizumab+ Interferon-Alfa
Comments P value was based on 1-sided stratified log-rank test (stratification factors: prior nephrectomy [yes/no] and MSKCC risk factors [good/intermediate/poor] at time of randomization). The hazard ratio and corresponding 95% CI from the stratified cox proportional hazard model were also presented.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
0.9 to 1.3
Estimation Comments [Not Specified]
Time Frame Adverse events were collected and reported from the signing of the informed consent until end of treatment but no later than 30 days after the last dose of study medication.
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Bevacizumab+Temsirolimus Bevacizumab+ Interferon-Alfa
Hide Arm/Group Description Bevacizumab 10 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with temsirolimus 25 mg intravenous infusion over at least 30 minutes once a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death. Bevacizumab 10 mg/kg intravenous infusion over 90 minutes, 60 minutes or 30 minutes depending on the participant’s tolerability every other week along with interferon-alfa (IFN) 9 million units (MU) subcutaneous injection every 3 times a week. Treatment was continued until disease progression, unacceptable toxicities, withdrawal of consent, or death.
All-Cause Mortality
Bevacizumab+Temsirolimus Bevacizumab+ Interferon-Alfa
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab+Temsirolimus Bevacizumab+ Interferon-Alfa
Affected / at Risk (%) Affected / at Risk (%)
Total   184/393 (46.82%)   158/391 (40.41%) 
Blood and lymphatic system disorders     
Anaemia * 1  10/393 (2.54%)  12/391 (3.07%) 
Disseminated intravascular coagulation * 1  0/393 (0.00%)  1/391 (0.26%) 
Neutropenia * 1  0/393 (0.00%)  1/391 (0.26%) 
Thrombocytopenia * 1  0/393 (0.00%)  1/391 (0.26%) 
Cardiac disorders     
Acute coronary syndrome * 1  1/393 (0.25%)  0/391 (0.00%) 
Acute myocardial infarction * 1  1/393 (0.25%)  1/391 (0.26%) 
Angina pectoris * 1  0/393 (0.00%)  1/391 (0.26%) 
Atrial fibrillation * 1  0/393 (0.00%)  1/391 (0.26%) 
Cardiac failure * 1  3/393 (0.76%)  0/391 (0.00%) 
Cardiac valve disease * 1  1/393 (0.25%)  0/391 (0.00%) 
Cardiopulmonary failure * 1  1/393 (0.25%)  1/391 (0.26%) 
Coronary artery disease * 1  1/393 (0.25%)  0/391 (0.00%) 
Coronary ostial stenosis * 1  0/393 (0.00%)  1/391 (0.26%) 
Left ventricular dysfunction * 1  0/393 (0.00%)  1/391 (0.26%) 
Cardio-Respiratory Arrest * 1  0/393 (0.00%)  1/391 (0.26%) 
Ear and labyrinth disorders     
Vertigo * 1  0/393 (0.00%)  1/391 (0.26%) 
Eye disorders     
Retinopathy * 1  0/393 (0.00%)  2/391 (0.51%) 
Vitreous floaters * 1  0/393 (0.00%)  1/391 (0.26%) 
Gastrointestinal disorders     
Abdominal pain * 1  8/393 (2.04%)  6/391 (1.53%) 
Anal fissure * 1  2/393 (0.51%)  0/391 (0.00%) 
Anal fistula * 1  2/393 (0.51%)  2/391 (0.51%) 
Anal haemorrhage * 1  1/393 (0.25%)  0/391 (0.00%) 
Ascites * 1  0/393 (0.00%)  1/391 (0.26%) 
Colitis * 1  2/393 (0.51%)  0/391 (0.00%) 
Constipation * 1  0/393 (0.00%)  1/391 (0.26%) 
Diarrhoea * 1  7/393 (1.78%)  5/391 (1.28%) 
Gastric fistula * 1  0/393 (0.00%)  1/391 (0.26%) 
Gastric ulcer haemorrhage * 1  1/393 (0.25%)  0/391 (0.00%) 
Gastritis * 1  2/393 (0.51%)  0/391 (0.00%) 
Gastrointestinal haemorrhage * 1  0/393 (0.00%)  1/391 (0.26%) 
Gastrointestinal perforation * 1  0/393 (0.00%)  1/391 (0.26%) 
Gastrooesophageal reflux disease * 1  1/393 (0.25%)  0/391 (0.00%) 
Haemorrhoidal haemorrhage * 1  0/393 (0.00%)  1/391 (0.26%) 
Haemorrhoids * 1  1/393 (0.25%)  0/391 (0.00%) 
Ileal perforation * 1  1/393 (0.25%)  0/391 (0.00%) 
Ileus * 1  1/393 (0.25%)  1/391 (0.26%) 
Ileus paralytic * 1  1/393 (0.25%)  0/391 (0.00%) 
Intestinal haemorrhage * 1  0/393 (0.00%)  1/391 (0.26%) 
Intestinal obstruction * 1  2/393 (0.51%)  0/391 (0.00%) 
Intestinal perforation * 1  1/393 (0.25%)  1/391 (0.26%) 
Large intestine perforation * 1  2/393 (0.51%)  1/391 (0.26%) 
Lower gastrointestinal haemorrhage * 1  1/393 (0.25%)  0/391 (0.00%) 
Mouth ulceration * 1  1/393 (0.25%)  0/391 (0.00%) 
Nausea * 1  1/393 (0.25%)  0/391 (0.00%) 
Painful defaecation * 1  1/393 (0.25%)  0/391 (0.00%) 
Pancreatitis * 1  2/393 (0.51%)  2/391 (0.51%) 
Pancreatitis acute * 1  1/393 (0.25%)  1/391 (0.26%) 
Proctitis * 1  1/393 (0.25%)  0/391 (0.00%) 
Rectal haemorrhage * 1  0/393 (0.00%)  1/391 (0.26%) 
Small intestinal obstruction * 1  0/393 (0.00%)  1/391 (0.26%) 
Stomatitis * 1  1/393 (0.25%)  1/391 (0.26%) 
Subileus * 1  0/393 (0.00%)  1/391 (0.26%) 
Upper gastrointestinal haemorrhage * 1  1/393 (0.25%)  2/391 (0.51%) 
Vomiting * 1  7/393 (1.78%)  2/391 (0.51%) 
General disorders     
Asthenia * 1  4/393 (1.02%)  5/391 (1.28%) 
Chills * 1  0/393 (0.00%)  1/391 (0.26%) 
Death * 1  0/393 (0.00%)  4/391 (1.02%) 
Disease progression * 1  13/393 (3.31%)  16/391 (4.09%) 
Fatigue * 1  1/393 (0.25%)  7/391 (1.79%) 
General physical health deterioration * 1  2/393 (0.51%)  6/391 (1.53%) 
Injury associated with device * 1  0/393 (0.00%)  1/391 (0.26%) 
Mucosal inflammation * 1  5/393 (1.27%)  0/391 (0.00%) 
Multi-organ failure * 1  2/393 (0.51%)  0/391 (0.00%) 
Non-cardiac chest pain * 1  0/393 (0.00%)  1/391 (0.26%) 
Oedema peripheral * 1  1/393 (0.25%)  0/391 (0.00%) 
Pain * 1  1/393 (0.25%)  2/391 (0.51%) 
Pyrexia * 1  9/393 (2.29%)  7/391 (1.79%) 
Sudden death * 1  5/393 (1.27%)  0/391 (0.00%) 
Condition Aggravated * 1  1/393 (0.25%)  0/391 (0.00%) 
Hepatobiliary disorders     
Acute hepatic failure * 1  0/393 (0.00%)  1/391 (0.26%) 
Cholangitis * 1  0/393 (0.00%)  1/391 (0.26%) 
Cholecystitis * 1  3/393 (0.76%)  0/391 (0.00%) 
Cholecystitis acute * 1  1/393 (0.25%)  0/391 (0.00%) 
Cholecystitis chronic * 1  0/393 (0.00%)  1/391 (0.26%) 
Cholelithiasis * 1  0/393 (0.00%)  1/391 (0.26%) 
Hepatitis toxic * 1  0/393 (0.00%)  1/391 (0.26%) 
Immune system disorders     
Contrast media allergy * 1  0/393 (0.00%)  1/391 (0.26%) 
Drug hypersensitivity * 1  1/393 (0.25%)  0/391 (0.00%) 
Infections and infestations     
Abdominal abscess * 1  0/393 (0.00%)  1/391 (0.26%) 
Abscess * 1  0/393 (0.00%)  1/391 (0.26%) 
Abscess intestinal * 1  0/393 (0.00%)  1/391 (0.26%) 
Anal abscess * 1  5/393 (1.27%)  2/391 (0.51%) 
Anorectal cellulitis * 1  1/393 (0.25%)  0/391 (0.00%) 
Appendicitis * 1  1/393 (0.25%)  1/391 (0.26%) 
Bronchitis * 1  0/393 (0.00%)  1/391 (0.26%) 
Bronchopneumonia * 1  3/393 (0.76%)  1/391 (0.26%) 
Cellulitis * 1  0/393 (0.00%)  1/391 (0.26%) 
Cystitis * 1  0/393 (0.00%)  1/391 (0.26%) 
Diarrhoea infectious * 1  1/393 (0.25%)  0/391 (0.00%) 
Erysipelas * 1  1/393 (0.25%)  0/391 (0.00%) 
Gangrene * 1  1/393 (0.25%)  0/391 (0.00%) 
Gastroenteritis viral * 1  0/393 (0.00%)  1/391 (0.26%) 
Haematoma infection * 1  0/393 (0.00%)  1/391 (0.26%) 
Haemorrhoid infection * 1  1/393 (0.25%)  0/391 (0.00%) 
Infection * 1  1/393 (0.25%)  1/391 (0.26%) 
Infectious pleural effusion * 1  2/393 (0.51%)  0/391 (0.00%) 
Injection site infection * 1  0/393 (0.00%)  1/391 (0.26%) 
Liver abscess * 1  1/393 (0.25%)  0/391 (0.00%) 
Lower respiratory tract infection * 1  1/393 (0.25%)  1/391 (0.26%) 
Lung abscess * 1  2/393 (0.51%)  0/391 (0.00%) 
Osteomyelitis chronic * 1  1/393 (0.25%)  0/391 (0.00%) 
Perirectal abscess * 1  2/393 (0.51%)  0/391 (0.00%) 
Peritoneal abscess * 1  1/393 (0.25%)  0/391 (0.00%) 
Peritonitis * 1  3/393 (0.76%)  2/391 (0.51%) 
Pharyngitis * 1  2/393 (0.51%)  0/391 (0.00%) 
Pneumonia * 1  16/393 (4.07%)  5/391 (1.28%) 
Post procedural infection * 1  0/393 (0.00%)  1/391 (0.26%) 
Rectal abscess * 1  1/393 (0.25%)  0/391 (0.00%) 
Respiratory tract infection * 1  2/393 (0.51%)  1/391 (0.26%) 
Scrotal abscess * 1  0/393 (0.00%)  1/391 (0.26%) 
Sepsis * 1  2/393 (0.51%)  4/391 (1.02%) 
Septic shock * 1  1/393 (0.25%)  2/391 (0.51%) 
Sinusitis * 1  2/393 (0.51%)  0/391 (0.00%) 
Subcutaneous abscess * 1  1/393 (0.25%)  1/391 (0.26%) 
Tooth infection * 1  2/393 (0.51%)  0/391 (0.00%) 
Urinary tract infection * 1  5/393 (1.27%)  4/391 (1.02%) 
Urosepsis * 1  1/393 (0.25%)  0/391 (0.00%) 
Viral infection * 1  1/393 (0.25%)  0/391 (0.00%) 
Viral pharyngitis * 1  1/393 (0.25%)  0/391 (0.00%) 
Colonic abscess * 1  0/393 (0.00%)  1/391 (0.26%) 
Epididymitis * 1  0/393 (0.00%)  1/391 (0.26%) 
Plasmodium Malariae Infection * 1  1/393 (0.25%)  0/391 (0.00%) 
Pulmonary Tuberculosis * 1  1/393 (0.25%)  0/391 (0.00%) 
Pyelonephritis Acute * 1  0/393 (0.00%)  1/391 (0.26%) 
Injury, poisoning and procedural complications     
Femoral neck fracture * 1  0/393 (0.00%)  1/391 (0.26%) 
Femur fracture * 1  1/393 (0.25%)  1/391 (0.26%) 
Head injury * 1  0/393 (0.00%)  1/391 (0.26%) 
Humerus fracture * 1  1/393 (0.25%)  0/391 (0.00%) 
Incisional hernia * 1  1/393 (0.25%)  0/391 (0.00%) 
Post procedural fistula * 1  1/393 (0.25%)  0/391 (0.00%) 
Seroma * 1  1/393 (0.25%)  0/391 (0.00%) 
Thoracic vertebral fracture * 1  0/393 (0.00%)  2/391 (0.51%) 
Ulna fracture * 1  0/393 (0.00%)  1/391 (0.26%) 
Wound complication * 1  0/393 (0.00%)  1/391 (0.26%) 
Investigations     
Blood pressure systolic decreased * 1  1/393 (0.25%)  0/391 (0.00%) 
Fibrin D dimer increased * 1  1/393 (0.25%)  0/391 (0.00%) 
Haemoglobin decreased * 1  0/393 (0.00%)  2/391 (0.51%) 
Protein urine present * 1  0/393 (0.00%)  1/391 (0.26%) 
Weight decreased * 1  0/393 (0.00%)  1/391 (0.26%) 
Blood Bilirubin Increased * 1  1/393 (0.25%)  0/391 (0.00%) 
Blood Creatinine Increased * 1  1/393 (0.25%)  0/391 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  2/393 (0.51%)  0/391 (0.00%) 
Dehydration * 1  4/393 (1.02%)  3/391 (0.77%) 
Diabetes mellitus * 1  1/393 (0.25%)  1/391 (0.26%) 
Diabetes mellitus inadequate control * 1  1/393 (0.25%)  0/391 (0.00%) 
Fluid retention * 1  1/393 (0.25%)  0/391 (0.00%) 
Gout * 1  0/393 (0.00%)  1/391 (0.26%) 
Hypercalcaemia * 1  3/393 (0.76%)  2/391 (0.51%) 
Hyperglycaemia * 1  4/393 (1.02%)  0/391 (0.00%) 
Hyperkalaemia * 1  1/393 (0.25%)  3/391 (0.77%) 
Hypoalbuminaemia * 1  1/393 (0.25%)  0/391 (0.00%) 
Hyponatraemia * 1  3/393 (0.76%)  2/391 (0.51%) 
Hypophagia * 1  1/393 (0.25%)  0/391 (0.00%) 
Ketosis * 1  1/393 (0.25%)  0/391 (0.00%) 
Tumour lysis syndrome * 1  1/393 (0.25%)  0/391 (0.00%) 
Type 2 diabetes mellitus * 1  1/393 (0.25%)  0/391 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  3/393 (0.76%)  1/391 (0.26%) 
Back pain * 1  3/393 (0.76%)  3/391 (0.77%) 
Bone lesion * 1  0/393 (0.00%)  1/391 (0.26%) 
Bone pain * 1  1/393 (0.25%)  0/391 (0.00%) 
Fistula * 1  0/393 (0.00%)  1/391 (0.26%) 
Flank pain * 1  0/393 (0.00%)  1/391 (0.26%) 
Gouty arthritis * 1  0/393 (0.00%)  1/391 (0.26%) 
Muscular weakness * 1  2/393 (0.51%)  2/391 (0.51%) 
Musculoskeletal chest pain * 1  1/393 (0.25%)  1/391 (0.26%) 
Myalgia * 1  0/393 (0.00%)  1/391 (0.26%) 
Pain in extremity * 1  0/393 (0.00%)  1/391 (0.26%) 
Pathological fracture * 1  2/393 (0.51%)  1/391 (0.26%) 
Spinal pain * 1  1/393 (0.25%)  0/391 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
B-cell lymphoma * 1  1/393 (0.25%)  0/391 (0.00%) 
Colon cancer * 1  1/393 (0.25%)  1/391 (0.26%) 
Metastases to lung * 1  1/393 (0.25%)  0/391 (0.00%) 
Metastases to lymph nodes * 1  0/393 (0.00%)  1/391 (0.26%) 
Metastases to meninges * 1  0/393 (0.00%)  1/391 (0.26%) 
Metastasis * 1  1/393 (0.25%)  0/391 (0.00%) 
Metastatic pain * 1  0/393 (0.00%)  1/391 (0.26%) 
Metastatic renal cell carcinoma * 1  1/393 (0.25%)  0/391 (0.00%) 
Neoplasm progression * 1  1/393 (0.25%)  0/391 (0.00%) 
Renal cell carcinoma * 1  4/393 (1.02%)  1/391 (0.26%) 
Tumour associated fever * 1  2/393 (0.51%)  0/391 (0.00%) 
Tumour haemorrhage * 1  1/393 (0.25%)  1/391 (0.26%) 
Tumour ulceration * 1  1/393 (0.25%)  0/391 (0.00%) 
Nervous system disorders     
Brain stem infarction * 1  0/393 (0.00%)  1/391 (0.26%) 
Cerebral haemorrhage * 1  1/393 (0.25%)  0/391 (0.00%) 
Cerebral infarction * 1  0/393 (0.00%)  2/391 (0.51%) 
Cerebrovascular accident * 1  0/393 (0.00%)  3/391 (0.77%) 
Dizziness * 1  1/393 (0.25%)  1/391 (0.26%) 
Epilepsy * 1  1/393 (0.25%)  1/391 (0.26%) 
Facial paresis * 1  1/393 (0.25%)  0/391 (0.00%) 
Haemorrhage intracranial * 1  0/393 (0.00%)  1/391 (0.26%) 
Haemorrhagic stroke * 1  0/393 (0.00%)  2/391 (0.51%) 
Headache * 1  4/393 (1.02%)  2/391 (0.51%) 
Hypertensive encephalopathy * 1  1/393 (0.25%)  0/391 (0.00%) 
Loss of consciousness * 1  0/393 (0.00%)  1/391 (0.26%) 
Mental impairment * 1  0/393 (0.00%)  1/391 (0.26%) 
Somnolence * 1  1/393 (0.25%)  0/391 (0.00%) 
Spinal cord compression * 1  1/393 (0.25%)  1/391 (0.26%) 
Syncope * 1  0/393 (0.00%)  4/391 (1.02%) 
Transient ischaemic attack * 1  0/393 (0.00%)  4/391 (1.02%) 
Tremor * 1  0/393 (0.00%)  1/391 (0.26%) 
Balance Disorder * 1  1/393 (0.25%)  0/391 (0.00%) 
Central Nervous System Haemorrhage * 1  0/393 (0.00%)  1/391 (0.26%) 
Seizure * 1  3/393 (0.76%)  1/391 (0.26%) 
Toxic Encephalopathy * 1  0/393 (0.00%)  1/391 (0.26%) 
Vascular Encephalopathy * 1  0/393 (0.00%)  1/391 (0.26%) 
Psychiatric disorders     
Confusional state * 1  2/393 (0.51%)  3/391 (0.77%) 
Completed Suicide * 1  0/393 (0.00%)  1/391 (0.26%) 
Depression * 1  0/393 (0.00%)  1/391 (0.26%) 
Renal and urinary disorders     
Nephrectasia * 1  0/393 (0.00%)  1/391 (0.26%) 
Nephrolithiasis * 1  0/393 (0.00%)  1/391 (0.26%) 
Nephrotic syndrome * 1  4/393 (1.02%)  2/391 (0.51%) 
Proteinuria * 1  2/393 (0.51%)  3/391 (0.77%) 
Renal disorder * 1  1/393 (0.25%)  0/391 (0.00%) 
Renal failure * 1  5/393 (1.27%)  2/391 (0.51%) 
Renal impairment * 1  1/393 (0.25%)  0/391 (0.00%) 
Ureteral disorder * 1  0/393 (0.00%)  1/391 (0.26%) 
Ureteric obstruction * 1  1/393 (0.25%)  0/391 (0.00%) 
Ureteric stenosis * 1  0/393 (0.00%)  1/391 (0.26%) 
Urinary retention * 1  1/393 (0.25%)  0/391 (0.00%) 
Acute Kidney Injury * 1  4/393 (1.02%)  3/391 (0.77%) 
Reproductive system and breast disorders     
Benign prostatic hyperplasia * 1  1/393 (0.25%)  0/391 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Aspiration * 1  1/393 (0.25%)  0/391 (0.00%) 
Atelectasis * 1  1/393 (0.25%)  0/391 (0.00%) 
Bronchospasm * 1  2/393 (0.51%)  0/391 (0.00%) 
Cough * 1  1/393 (0.25%)  1/391 (0.26%) 
Dyspnoea * 1  3/393 (0.76%)  10/391 (2.56%) 
Epistaxis * 1  2/393 (0.51%)  2/391 (0.51%) 
Haemoptysis * 1  2/393 (0.51%)  3/391 (0.77%) 
Hiccups * 1  0/393 (0.00%)  1/391 (0.26%) 
Interstitial lung disease * 1  2/393 (0.51%)  0/391 (0.00%) 
Lung disorder * 1  1/393 (0.25%)  0/391 (0.00%) 
Nasal septum disorder * 1  0/393 (0.00%)  1/391 (0.26%) 
Oropharyngeal pain * 1  1/393 (0.25%)  0/391 (0.00%) 
Orthopnoea * 1  1/393 (0.25%)  0/391 (0.00%) 
Pleural effusion * 1  2/393 (0.51%)  2/391 (0.51%) 
Pleuritic pain * 1  0/393 (0.00%)  2/391 (0.51%) 
Pneumonia aspiration * 1  0/393 (0.00%)  1/391 (0.26%) 
Pneumonitis * 1  4/393 (1.02%)  0/391 (0.00%) 
Pneumothorax * 1  1/393 (0.25%)  0/391 (0.00%) 
Pulmonary artery thrombosis * 1  1/393 (0.25%)  0/391 (0.00%) 
Pulmonary embolism * 1  5/393 (1.27%)  4/391 (1.02%) 
Pulmonary hypertension * 1  1/393 (0.25%)  0/391 (0.00%) 
Respiratory failure * 1  3/393 (0.76%)  1/391 (0.26%) 
Sputum discoloured * 1  0/393 (0.00%)  1/391 (0.26%) 
Skin and subcutaneous tissue disorders     
Dermatitis allergic * 1  1/393 (0.25%)  0/391 (0.00%) 
Skin haemorrhage * 1  1/393 (0.25%)  0/391 (0.00%) 
Skin ulcer * 1  1/393 (0.25%)  1/391 (0.26%) 
Surgical and medical procedures     
Malignant tumour excision * 1  1/393 (0.25%)  0/391 (0.00%) 
Cancer Surgery * 1  1/393 (0.25%)  0/391 (0.00%) 
Vascular disorders     
Arteriosclerosis * 1  0/393 (0.00%)  1/391 (0.26%) 
Circulatory collapse * 1  1/393 (0.25%)  1/391 (0.26%) 
Deep vein thrombosis * 1  2/393 (0.51%)  1/391 (0.26%) 
Haematoma * 1  0/393 (0.00%)  1/391 (0.26%) 
Haemorrhage * 1  0/393 (0.00%)  1/391 (0.26%) 
Hypertension * 1  6/393 (1.53%)  4/391 (1.02%) 
Hypertensive crisis * 1  1/393 (0.25%)  1/391 (0.26%) 
Lymphoedema * 1  1/393 (0.25%)  0/391 (0.00%) 
Peripheral ischaemia * 1  1/393 (0.25%)  0/391 (0.00%) 
Thrombosis * 1  1/393 (0.25%)  0/391 (0.00%) 
Venous thrombosis * 1  1/393 (0.25%)  0/391 (0.00%) 
Peripheral Venous Disease * 1  1/393 (0.25%)  0/391 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bevacizumab+Temsirolimus Bevacizumab+ Interferon-Alfa
Affected / at Risk (%) Affected / at Risk (%)
Total   383/393 (97.46%)   378/391 (96.68%) 
Blood and lymphatic system disorders     
Anaemia * 1  80/393 (20.36%)  66/391 (16.88%) 
Leukopenia * 1  17/393 (4.33%)  40/391 (10.23%) 
Lymphopenia * 1  24/393 (6.11%)  38/391 (9.72%) 
Neutropenia * 1  18/393 (4.58%)  66/391 (16.88%) 
Thrombocytopenia * 1  50/393 (12.72%)  40/391 (10.23%) 
Ear and labyrinth disorders     
Vertigo * 1  4/393 (1.02%)  20/391 (5.12%) 
Gastrointestinal disorders     
Abdominal pain * 1  48/393 (12.21%)  42/391 (10.74%) 
Abdominal pain upper * 1  31/393 (7.89%)  21/391 (5.37%) 
Constipation * 1  43/393 (10.94%)  48/391 (12.28%) 
Diarrhoea * 1  126/393 (32.06%)  86/391 (21.99%) 
Gingival bleeding * 1  5/393 (1.27%)  21/391 (5.37%) 
Haemorrhoids * 1  28/393 (7.12%)  13/391 (3.32%) 
Nausea * 1  69/393 (17.56%)  78/391 (19.95%) 
Stomatitis * 1  102/393 (25.95%)  39/391 (9.97%) 
Toothache * 1  37/393 (9.41%)  14/391 (3.58%) 
Vomiting * 1  53/393 (13.49%)  53/391 (13.55%) 
General disorders     
Asthenia * 1  95/393 (24.17%)  113/391 (28.90%) 
Chills * 1  15/393 (3.82%)  44/391 (11.25%) 
Fatigue * 1  92/393 (23.41%)  122/391 (31.20%) 
Influenza like illness * 1  14/393 (3.56%)  48/391 (12.28%) 
Mucosal inflammation * 1  105/393 (26.72%)  40/391 (10.23%) 
Oedema peripheral * 1  67/393 (17.05%)  32/391 (8.18%) 
Pyrexia * 1  79/393 (20.10%)  154/391 (39.39%) 
Infections and infestations     
Upper respiratory tract infection * 1  20/393 (5.09%)  15/391 (3.84%) 
Urinary tract infection * 1  23/393 (5.85%)  21/391 (5.37%) 
Investigations     
Alanine aminotransferase increased * 1  38/393 (9.67%)  35/391 (8.95%) 
Aspartate aminotransferase increased * 1  33/393 (8.40%)  41/391 (10.49%) 
Blood creatinine increased * 1  40/393 (10.18%)  25/391 (6.39%) 
Weight decreased * 1  90/393 (22.90%)  93/391 (23.79%) 
Blood Alkaline Phosphatase Increased * 1  20/393 (5.09%)  14/391 (3.58%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  103/393 (26.21%)  127/391 (32.48%) 
Hypercholesterolaemia * 1  126/393 (32.06%)  39/391 (9.97%) 
Hyperglycaemia * 1  86/393 (21.88%)  19/391 (4.86%) 
Hyperkalaemia * 1  29/393 (7.38%)  37/391 (9.46%) 
Hypertriglyceridaemia * 1  114/393 (29.01%)  82/391 (20.97%) 
Hypocalcaemia * 1  24/393 (6.11%)  13/391 (3.32%) 
Hypomagnesaemia * 1  20/393 (5.09%)  16/391 (4.09%) 
Hyponatraemia * 1  23/393 (5.85%)  21/391 (5.37%) 
Hypophosphataemia * 1  40/393 (10.18%)  18/391 (4.60%) 
Hypokalaemia * 1  20/393 (5.09%)  4/391 (1.02%) 
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  52/393 (13.23%)  49/391 (12.53%) 
Back pain * 1  47/393 (11.96%)  53/391 (13.55%) 
Bone pain * 1  18/393 (4.58%)  22/391 (5.63%) 
Musculoskeletal chest pain * 1  27/393 (6.87%)  19/391 (4.86%) 
Musculoskeletal pain * 1  14/393 (3.56%)  28/391 (7.16%) 
Myalgia * 1  19/393 (4.83%)  60/391 (15.35%) 
Pain in extremity * 1  43/393 (10.94%)  35/391 (8.95%) 
Nervous system disorders     
Dizziness * 1  29/393 (7.38%)  37/391 (9.46%) 
Dysgeusia * 1  33/393 (8.40%)  21/391 (5.37%) 
Headache * 1  77/393 (19.59%)  82/391 (20.97%) 
Psychiatric disorders     
Anxiety * 1  7/393 (1.78%)  21/391 (5.37%) 
Depression * 1  11/393 (2.80%)  22/391 (5.63%) 
Insomnia * 1  28/393 (7.12%)  31/391 (7.93%) 
Renal and urinary disorders     
Proteinuria * 1  143/393 (36.39%)  111/391 (28.39%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  79/393 (20.10%)  70/391 (17.90%) 
Dysphonia * 1  13/393 (3.31%)  30/391 (7.67%) 
Dyspnoea * 1  36/393 (9.16%)  49/391 (12.53%) 
Epistaxis * 1  110/393 (27.99%)  82/391 (20.97%) 
Oropharyngeal pain * 1  28/393 (7.12%)  16/391 (4.09%) 
Skin and subcutaneous tissue disorders     
Dry skin * 1  27/393 (6.87%)  13/391 (3.32%) 
Pruritus * 1  60/393 (15.27%)  26/391 (6.65%) 
Rash * 1  126/393 (32.06%)  32/391 (8.18%) 
Vascular disorders     
Hypertension * 1  128/393 (32.57%)  102/391 (26.09%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.0
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00631371     History of Changes
Other Study ID Numbers: 3066K1-3311
B1771006 ( Other Identifier: Alias Study Number )
2007-003793-26 ( EudraCT Number )
First Submitted: February 28, 2008
First Posted: March 7, 2008
Results First Submitted: April 18, 2013
Results First Posted: June 4, 2013
Last Update Posted: April 27, 2016