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Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery (ASSURE)

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ClinicalTrials.gov Identifier: NCT00326898
Recruitment Status : Completed
First Posted : May 17, 2006
Results First Posted : December 12, 2016
Last Update Posted : February 8, 2017
Sponsor:
Collaborators:
ECOG-ACRIN Cancer Research Group
NCIC Clinical Trials Group
Southwest Oncology Group
Cancer and Leukemia Group B
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Stage I Renal Cell Cancer
Stage II Renal Cell Cancer
Stage III Renal Cell Cancer
Interventions Other: Placebo
Drug: Sorafenib
Drug: Sunitinib
Enrollment 1943
Recruitment Details The study was activated on April 24, 2006 and closed to accrual on September 1, 2010, after accrual of 1943 patients.
Pre-assignment Details  
Arm/Group Title Arm A (Sunitinib + Sorafenib Placebo) Arm B (Sorafenib + Sunitinib Placebo) Arm C (Sunitinib Placebo + Sorafenib Placebo)
Hide Arm/Group Description Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks. Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed. Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
Period Title: Overall Study
Started 647 649 647
Patients With Toxicity Data 625 628 626
Patients With Clear Cell Histology 542 540 540
Patients With >=1 Follow-up MUGA Scan 513 510 580
Completed 296 306 444
Not Completed 351 343 203
Reason Not Completed
Disease progression             52             54             102
Adverse Event             124             128             33
Death             2             0             0
Withdrawal by Subject             134             128             32
Alternative therapy             1             0             0
Other complicating disease             5             5             4
Other/Missing/Unknown             33             28             32
Arm/Group Title Arm A (Sunitinib + Sorafenib Placebo) Arm B (Sorafenib + Sunitinib Placebo) Arm C (Sunitinib Placebo + Sorafenib Placebo) Total
Hide Arm/Group Description Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks. Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed. Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B. Total of all reporting groups
Overall Number of Baseline Participants 647 649 647 1943
Hide Baseline Analysis Population Description
All randomized patients
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 647 participants 649 participants 647 participants 1943 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
489
  75.6%
507
  78.1%
500
  77.3%
1496
  77.0%
>=65 years
158
  24.4%
142
  21.9%
147
  22.7%
447
  23.0%
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 647 participants 649 participants 647 participants 1943 participants
Female
218
  33.7%
212
  32.7%
204
  31.5%
634
  32.6%
Male
429
  66.3%
437
  67.3%
443
  68.5%
1309
  67.4%
1.Primary Outcome
Title Disease-free Survival (DFS)
Hide Description Disease-free survival (DFS) is defined as time from randomization to recurrence, development of second primary cancer (except localized breast or prostate cancer or nonmelanoma skin cancer), or death from any cause. Patients who were alive without recurrence or qualifying second primary cancer were censored at the date of last disease evaluation.
Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized patients
Arm/Group Title Arm A (Sunitinib + Sorafenib Placebo) Arm B (Sorafenib + Sunitinib Placebo) Arm C (Sunitinib Placebo + Sorafenib Placebo)
Hide Arm/Group Description:
Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
Overall Number of Participants Analyzed 647 649 647
Median (97.5% Confidence Interval)
Unit of Measure: years
5.8 [1] 
(5.0 to NA)
6.1 [1] 
(4.8 to NA)
6.6
(5.3 to 7.8)
[1]
The upper limit of the 97.5% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Sunitinib + Sorafenib Placebo), Arm C (Sunitinib Placebo + Sorafenib Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments [Not Specified]
Method Stratified logrank test
Comments Stratified logrank test was performed. Stratification factors include basis of risk group, histologic subtype, performance status and type of surgery.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.02
Confidence Interval (2-Sided) 97.5%
0.85 to 1.23
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm B (Sorafenib + Sunitinib Placebo), Arm C (Sunitinib Placebo + Sorafenib Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments [Not Specified]
Method Stratified logrank test
Comments Stratified logrank test was performed. Stratification factors include basis of risk group, histologic subtype, performance status and type of surgery.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.97
Confidence Interval (2-Sided) 97.5%
0.80 to 1.17
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 5-year Overall Survival Rate
Hide Description Overall survival is defined as the time from randomization to death from any cause. Patients without a date of death were censored at the date of last contact. Kaplan-Meier method was used to estimate 5-year survival rate.
Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized patients
Arm/Group Title Arm A (Sunitinib + Sorafenib Placebo) Arm B (Sorafenib + Sunitinib Placebo) Arm C (Sunitinib Placebo + Sorafenib Placebo)
Hide Arm/Group Description:
Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
Overall Number of Participants Analyzed 647 649 647
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: proportion of participants
0.779
(0.741 to 0.819)
0.805
(0.768 to 0.842)
0.803
(0.767 to 0.840)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Sunitinib + Sorafenib Placebo), Arm C (Sunitinib Placebo + Sorafenib Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.17
Confidence Interval (2-Sided) 97.5%
0.90 to 1.52
Estimation Comments Hazard ratio was estimated using stratified proportional hazards model with Arm C (placebo arm) as the reference group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm B (Sorafenib + Sunitinib Placebo), Arm C (Sunitinib Placebo + Sorafenib Placebo)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.98
Confidence Interval (2-Sided) 97.5%
0.75 to 1.28
Estimation Comments Hazard ratio was estimated using stratified proportional hazards model with Arm C (placebo arm) as the reference group.
3.Secondary Outcome
Title Proportion of Patients With Cardiac Events
Hide Description Cardiac event is defined as left ventricular ejection fraction (LVEF) below the institutional lower limit of normal, where the decrease was >15% absolute percentage points from baseline within 6 months.
Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with at least 1 follow-up MUGA scan were included in this analysis.
Arm/Group Title Arm A (Sunitinib + Sorafenib Placebo) Arm B (Sorafenib + Sunitinib Placebo) Arm C (Sunitinib Placebo + Sorafenib Placebo)
Hide Arm/Group Description:
Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
Overall Number of Participants Analyzed 513 510 580
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Proportion of participants
0.017
(0.009 to 0.030)
0.013
(0.006 to 0.026)
0.008
(0.003 to 0.018)
4.Secondary Outcome
Title 5-year Disease-free Survival (DFS) Rate Among Patients With Clear Cell Histology
Hide Description Disease-free survival (DFS) is defined as time from randomization to recurrence, development of second primary cancer (except localized breast or prostate cancer or nonmelanoma skin cancer), or death from any cause. Patients who were alive without recurrence or qualifying second primary cancer were censored at the date of last disease evaluation. 5-year DFS rate is the proportion of patients who are alive and disease-free at 5 years based on the Kaplan-Meier estimate.
Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with clear cell histology were included in this analysis.
Arm/Group Title Arm A (Sunitinib + Sorafenib Placebo) Arm B (Sorafenib + Sunitinib Placebo) Arm C (Sunitinib Placebo + Sorafenib Placebo)
Hide Arm/Group Description:
Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
Overall Number of Participants Analyzed 542 540 540
Measure Type: Number
Number (97.5% Confidence Interval)
Unit of Measure: proportion of participants
0.534
(0.484 to 0.590)
0.527
(0.478 to 0.582)
0.560
(0.511 to 0.614)
5.Other Pre-specified Outcome
Title The Association Between Angiogenesis Markers and Disease-free Survival
Hide Description [Not Specified]
Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title The Association Between Disease-free Survival and the Frequency of Oncogene as Well as Tumor Suppressor Gene Mutations
Hide Description [Not Specified]
Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title The Association Between Tumor and Genetic Polymorphisms and Disease-free Survival
Hide Description [Not Specified]
Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title The Association Between Deoxyribonucleic Acid (DNA) Methylation Profiles and Disease-free Survival
Hide Description [Not Specified]
Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
Outcome Measure Data Not Reported
9.Other Pre-specified Outcome
Title The Relationship of Polymorphisms in Drug Metabolizing Enzymes With Steady State Concentrations of Sorafenib and Sunitinib in Selected Patients
Hide Description [Not Specified]
Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
Outcome Measure Data Not Reported
10.Other Pre-specified Outcome
Title The Effect of Vascular Endothelial Growth Factor (VEGF) Targeted Therapy on Circulating Endothelial Cells and Circulating Endothelial Progenitors
Hide Description [Not Specified]
Time Frame Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Patient-reported Fatigue Using Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale
Hide Description [Not Specified]
Time Frame Assessed at baseline, 10 weeks and 22 weeks
Outcome Measure Data Not Reported
12.Other Pre-specified Outcome
Title Patient-reported Fatigue Using the Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form
Hide Description PROMIS Fatigue short form is a newly developed state-of-the-science PROMIS measure for fatigue
Time Frame Assessed at baseline, 10 weeks and 22 weeks
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title The Association Between Scan Frequency and Development of Congestive Heart Failure
Hide Description [Not Specified]
Time Frame Assessed at 3, 6 and 12 months
Outcome Measure Data Not Reported
14.Other Pre-specified Outcome
Title Frequency of Clinically Significant Congestive Heart Failure (CHF) Grade 3 or Higher Using the Common Terminology Criteria for Adverse Events Version 4.0
Hide Description [Not Specified]
Time Frame Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
Outcome Measure Data Not Reported
Time Frame Assessed every 6 weeks while on treatment and for 30 days after the end of treatment
Adverse Event Reporting Description Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
 
Arm/Group Title Arm A (Sunitinib + Sorafenib Placebo) Arm B (Sorafenib + Sunitinib Placebo) Arm C (Sunitinib Placebo + Sorafenib Placebo)
Hide Arm/Group Description Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks. Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed. Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
All-Cause Mortality
Arm A (Sunitinib + Sorafenib Placebo) Arm B (Sorafenib + Sunitinib Placebo) Arm C (Sunitinib Placebo + Sorafenib Placebo)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Arm A (Sunitinib + Sorafenib Placebo) Arm B (Sorafenib + Sunitinib Placebo) Arm C (Sunitinib Placebo + Sorafenib Placebo)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   368/625 (58.88%)   424/628 (67.52%)   81/626 (12.94%) 
Blood and lymphatic system disorders       
Anemia  1  2/625 (0.32%)  1/628 (0.16%)  0/626 (0.00%) 
Thrombotic microangiopathy  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Febrile neutropenia  1  2/625 (0.32%)  0/628 (0.00%)  0/626 (0.00%) 
Cardiac disorders       
Heart block abnormality NOS  1  0/625 (0.00%)  0/628 (0.00%)  1/626 (0.16%) 
Atrial fibrillation  1  1/625 (0.16%)  0/628 (0.00%)  2/626 (0.32%) 
Atrial flutter  1  0/625 (0.00%)  0/628 (0.00%)  2/626 (0.32%) 
Sinus bradycardia  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Supraventricular tachycardia  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Bigeminy  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Cardiac-ischemia  1  1/625 (0.16%)  3/628 (0.48%)  4/626 (0.64%) 
Left ventricular systolic dysfunction  1  4/625 (0.64%)  4/628 (0.64%)  2/626 (0.32%) 
Cor Pulmonale  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
cardiac-other  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Cardiac/heart, pain  1  2/625 (0.32%)  3/628 (0.48%)  0/626 (0.00%) 
Ear and labyrinth disorders       
Hearing w/o audiogr not in monitor prg  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Endocrine disorders       
Adrenal insufficiency  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Hyopthyroidism  1  2/625 (0.32%)  0/628 (0.00%)  0/626 (0.00%) 
Eye disorders       
Cataract  1  0/625 (0.00%)  0/628 (0.00%)  1/626 (0.16%) 
Double vision  1  0/625 (0.00%)  0/628 (0.00%)  1/626 (0.16%) 
Retinal detachment  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Ocular-other  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Gastrointestinal disorders       
Colitis  1  0/625 (0.00%)  3/628 (0.48%)  0/626 (0.00%) 
Constipation  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Diarrhea w/o prior colostomy  1  57/625 (9.12%)  55/628 (8.76%)  2/626 (0.32%) 
Distention/bloating, abdominal  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Esophagitis  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Gastritis  1  1/625 (0.16%)  1/628 (0.16%)  0/626 (0.00%) 
Dyspepsia  1  14/625 (2.24%)  4/628 (0.64%)  1/626 (0.16%) 
Ileus  1  0/625 (0.00%)  0/628 (0.00%)  1/626 (0.16%) 
Muco/stomatitis by exam, oral cavity  1  2/625 (0.32%)  0/628 (0.00%)  0/626 (0.00%) 
Muco/stomatitis (symptom) oral cavity  1  3/625 (0.48%)  1/628 (0.16%)  0/626 (0.00%) 
Nausea  1  22/625 (3.52%)  5/628 (0.80%)  0/626 (0.00%) 
Perforation, colon  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Vomiting  1  11/625 (1.76%)  3/628 (0.48%)  1/626 (0.16%) 
Colon, hemorrhage  1  2/625 (0.32%)  0/628 (0.00%)  0/626 (0.00%) 
Lower GI, hemorrhage NOS  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Stomach, hemorrhage  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Pancreatitis  1  3/625 (0.48%)  1/628 (0.16%)  0/626 (0.00%) 
Abdomen, pain  1  4/625 (0.64%)  8/628 (1.27%)  2/626 (0.32%) 
Esophagus, pain  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Oral cavity, pain  1  1/625 (0.16%)  1/628 (0.16%)  0/626 (0.00%) 
Stomach, pain  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
General disorders       
Fatigue  1  108/625 (17.28%)  41/628 (6.53%)  15/626 (2.40%) 
Fever w/o neutropenia  1  1/625 (0.16%)  2/628 (0.32%)  0/626 (0.00%) 
Edema head and neck  1  3/625 (0.48%)  1/628 (0.16%)  0/626 (0.00%) 
Edema limb  1  2/625 (0.32%)  0/628 (0.00%)  0/626 (0.00%) 
Chest/thoracic pain NOS  1  4/625 (0.64%)  4/628 (0.64%)  0/626 (0.00%) 
Pain-other  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Flu-like syndrome  1  3/625 (0.48%)  0/628 (0.00%)  0/626 (0.00%) 
Hepatobiliary disorders       
Cholecystitis  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Liver dysfunction/failure  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Hepatic-other  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Immune system disorders       
Allergic reaction  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Infections and infestations       
Infection w/ gr3-4 neut, ileum  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Infection Gr0-2 neut, appendix  1  0/625 (0.00%)  0/628 (0.00%)  1/626 (0.16%) 
Infection Gr0-2 neut, colon  1  0/625 (0.00%)  2/628 (0.32%)  0/626 (0.00%) 
Infection Gr0-2 neut, kidney  1  1/625 (0.16%)  1/628 (0.16%)  0/626 (0.00%) 
Infection Gr0-2 neut, lung  1  2/625 (0.32%)  3/628 (0.48%)  2/626 (0.32%) 
Infection Gr0-2 neut, mediastinm  1  0/625 (0.00%)  0/628 (0.00%)  1/626 (0.16%) 
Infection Gr0-2 neut, mucosa  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Infection Gr0-2 neut, muscle  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Infection Gr0-2 neut, nerve-cranial  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Infection Gr0-2 neut, skin  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Infection Gr0-2 neut, urinary tract  1  1/625 (0.16%)  0/628 (0.00%)  1/626 (0.16%) 
Infection Gr0-2 neut, vagina  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Infection Gr0-2 neut, wound  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Infection w/ unk ANC skin (cellulitis)  1  0/625 (0.00%)  2/628 (0.32%)  0/626 (0.00%) 
Infection w/ unk ANC urinary tract NOS  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Infection Gr0-2 neut, blood  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Infection-other  1  1/625 (0.16%)  1/628 (0.16%)  0/626 (0.00%) 
Injury, poisoning and procedural complications       
Wound - non-infectious  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Vascular access,Thrombosis/embolism  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Investigations       
Leukocytes decreased  1  3/625 (0.48%)  0/628 (0.00%)  0/626 (0.00%) 
Neutrophils decreased  1  7/625 (1.12%)  2/628 (0.32%)  0/626 (0.00%) 
Platelets decreased  1  13/625 (2.08%)  2/628 (0.32%)  1/626 (0.16%) 
Weight gain  1  0/625 (0.00%)  0/628 (0.00%)  2/626 (0.32%) 
Alanine aminotransferase increased  1  4/625 (0.64%)  4/628 (0.64%)  0/626 (0.00%) 
Serum amylase increased  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Aspartate aminotransferase increased  1  6/625 (0.96%)  4/628 (0.64%)  0/626 (0.00%) 
Blood bilirubin increased  1  1/625 (0.16%)  1/628 (0.16%)  1/626 (0.16%) 
Hypercholesterolemia  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
CPK increased  1  1/625 (0.16%)  1/628 (0.16%)  0/626 (0.00%) 
Creatinine increased  1  1/625 (0.16%)  3/628 (0.48%)  0/626 (0.00%) 
Lipase increased  1  4/625 (0.64%)  3/628 (0.48%)  1/626 (0.16%) 
Metabolism and nutrition disorders       
Anorexia  1  11/625 (1.76%)  5/628 (0.80%)  0/626 (0.00%) 
Dehydration  1  10/625 (1.60%)  3/628 (0.48%)  0/626 (0.00%) 
Hypoalbuminemia  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Hypocalcemia  1  1/625 (0.16%)  1/628 (0.16%)  0/626 (0.00%) 
Hyperglycemia  1  0/625 (0.00%)  1/628 (0.16%)  1/626 (0.16%) 
Hypophosphatemia  1  1/625 (0.16%)  1/628 (0.16%)  0/626 (0.00%) 
Hyperkalemia  1  3/625 (0.48%)  1/628 (0.16%)  0/626 (0.00%) 
Hypokalemia  1  2/625 (0.32%)  1/628 (0.16%)  0/626 (0.00%) 
Hypernatremia  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Hyponatremia  1  1/625 (0.16%)  5/628 (0.80%)  4/626 (0.64%) 
Hypertriglyceridemia  1  2/625 (0.32%)  0/628 (0.00%)  0/626 (0.00%) 
Hyperuricemia  1  0/625 (0.00%)  1/628 (0.16%)  3/626 (0.48%) 
Musculoskeletal and connective tissue disorders       
Nonneuropathic upper extr muscle weak  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Nonneuropathic left-side muscle weak  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Nonneuropathic right-side muscle weak  1  0/625 (0.00%)  0/628 (0.00%)  1/626 (0.16%) 
Nonneuropathic generalized weakness  1  1/625 (0.16%)  1/628 (0.16%)  1/626 (0.16%) 
Myositis  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Musculoskeletal/soft tissue-other  1  0/625 (0.00%)  2/628 (0.32%)  0/626 (0.00%) 
Back, pain  1  1/625 (0.16%)  3/628 (0.48%)  0/626 (0.00%) 
Bone, pain  1  2/625 (0.32%)  1/628 (0.16%)  0/626 (0.00%) 
Extremity-limb, pain  1  4/625 (0.64%)  3/628 (0.48%)  0/626 (0.00%) 
Joint, pain  1  8/625 (1.28%)  8/628 (1.27%)  3/626 (0.48%) 
Muscle, pain  1  2/625 (0.32%)  8/628 (1.27%)  1/626 (0.16%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Secondary malignancy  1  0/625 (0.00%)  1/628 (0.16%)  1/626 (0.16%) 
Nervous system disorders       
Vasovagal episode  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Ataxia  1  0/625 (0.00%)  0/628 (0.00%)  1/626 (0.16%) 
CNS cerebrovascular ischemia  1  4/625 (0.64%)  0/628 (0.00%)  1/626 (0.16%) 
Cognitive disturbance  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Dizziness  1  4/625 (0.64%)  2/628 (0.32%)  2/626 (0.32%) 
Memory impairment  1  1/625 (0.16%)  0/628 (0.00%)  1/626 (0.16%) 
Neuropathy-motor  1  3/625 (0.48%)  1/628 (0.16%)  0/626 (0.00%) 
Neuropathy-sensory  1  3/625 (0.48%)  12/628 (1.91%)  3/626 (0.48%) 
Syncope  1  4/625 (0.64%)  2/628 (0.32%)  0/626 (0.00%) 
Head/headache  1  6/625 (0.96%)  4/628 (0.64%)  0/626 (0.00%) 
Psychiatric disorders       
Insomnia  1  0/625 (0.00%)  4/628 (0.64%)  0/626 (0.00%) 
Confusion  1  2/625 (0.32%)  0/628 (0.00%)  1/626 (0.16%) 
Anxiety  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Depression  1  1/625 (0.16%)  2/628 (0.32%)  2/626 (0.32%) 
Renal and urinary disorders       
Kidney, hemorrhage  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Proteinuria  1  2/625 (0.32%)  2/628 (0.32%)  0/626 (0.00%) 
Renal failure  1  6/625 (0.96%)  4/628 (0.64%)  0/626 (0.00%) 
Renal/GU-other  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Reproductive system and breast disorders       
Sexual/Reproductive function-Other  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Pulmonary hypertension  1  0/625 (0.00%)  0/628 (0.00%)  1/626 (0.16%) 
Muco/stomatitis (symptom) pharynx  1  24/625 (3.84%)  14/628 (2.23%)  0/626 (0.00%) 
Nose, hemorrhage  1  3/625 (0.48%)  0/628 (0.00%)  0/626 (0.00%) 
Dyspnea  1  4/625 (0.64%)  4/628 (0.64%)  2/626 (0.32%) 
Pleural effusion (non-malignant)  1  1/625 (0.16%)  1/628 (0.16%)  0/626 (0.00%) 
Voice changes/dysarthria  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Skin and subcutaneous tissue disorders       
Dry skin  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Nail changes  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Pruritus/itching  1  1/625 (0.16%)  11/628 (1.75%)  1/626 (0.16%) 
Rash/desquamation  1  15/625 (2.40%)  93/628 (14.81%)  3/626 (0.48%) 
Rash: acne/acneiform  1  0/625 (0.00%)  2/628 (0.32%)  0/626 (0.00%) 
Erythema multiforme  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Hand-foot reaction  1  94/625 (15.04%)  208/628 (33.12%)  7/626 (1.12%) 
Urticaria  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Scalp, pain  1  0/625 (0.00%)  2/628 (0.32%)  0/626 (0.00%) 
Skin, pain  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Vascular disorders       
Hypertension  1  104/625 (16.64%)  96/628 (15.29%)  15/626 (2.40%) 
Hypotension  1  1/625 (0.16%)  0/628 (0.00%)  0/626 (0.00%) 
Thrombosis/thrombus/embolism  1  3/625 (0.48%)  5/628 (0.80%)  1/626 (0.16%) 
Vascular-Other (Specify)  1  0/625 (0.00%)  1/628 (0.16%)  0/626 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A (Sunitinib + Sorafenib Placebo) Arm B (Sorafenib + Sunitinib Placebo) Arm C (Sunitinib Placebo + Sorafenib Placebo)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   116/625 (18.56%)   117/628 (18.63%)   57/626 (9.11%) 
Gastrointestinal disorders       
Diarrhea w/o prior colostomy  1  41/625 (6.56%)  40/628 (6.37%)  13/626 (2.08%) 
Nausea  1  33/625 (5.28%)  21/628 (3.34%)  11/626 (1.76%) 
General disorders       
Fatigue  1  62/625 (9.92%)  58/628 (9.24%)  31/626 (4.95%) 
Skin and subcutaneous tissue disorders       
Rash/desquamation  1  17/625 (2.72%)  43/628 (6.85%)  15/626 (2.40%) 
Hand-foot reaction  1  36/625 (5.76%)  52/628 (8.28%)  7/626 (1.12%) 
Vascular disorders       
Hypertension  1  38/625 (6.08%)  38/628 (6.05%)  10/626 (1.60%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
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.
Results Point of Contact
Name/Title: Study Statistician
Organization: ECOG-ACRIN Statistical Office
Phone: 617-632-3012
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00326898     History of Changes
Other Study ID Numbers: NCI-2009-00534
NCI-2009-00534 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
E2805 ( Other Identifier: ECOG-ACRIN Cancer Research Group )
U10CA023318 ( U.S. NIH Grant/Contract )
First Submitted: May 16, 2006
First Posted: May 17, 2006
Results First Submitted: October 18, 2016
Results First Posted: December 12, 2016
Last Update Posted: February 8, 2017