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Trial record 3 of 10 for:    "Clear Cell Renal Cell Carcinoma" | "Interferon alpha-2"

Sorafenib Tosylate With or Without Recombinant Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer

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ClinicalTrials.gov Identifier: NCT00126594
Recruitment Status : Completed
First Posted : August 4, 2005
Results First Posted : September 16, 2016
Last Update Posted : September 16, 2016
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Clear Cell Renal Cell Carcinoma
Recurrent Renal Cell Carcinoma
Stage IV Renal Cell Cancer
Interventions Drug: Sorafenib Tosylate
Biological: Recombinant Interferon Alfa-2b
Other: Laboratory Biomarker Analysis
Enrollment 80
Recruitment Details Recruitment Period: June 23, 2005 to June 28, 2007. All recruitment done at The University of Texas (UT) MD Anderson Cancer Center.
Pre-assignment Details  
Arm/Group Title Sorafenib Tosylate Sorafenib Tosylate, Recombinant Interferon Alfa-2b
Hide Arm/Group Description Arm I: Oral Sorafenib 400 mg twice daily on days 1-28. Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
Period Title: Overall Study
Started 40 40
Completed 1 3
Not Completed 39 37
Reason Not Completed
Ineligible             2             0
Withdrawal by Subject             0             4
Physician Decision             1             3
Adverse Event             7             5
Non-compliance             0             1
Disease Progression             29             24
Arm/Group Title Sorafenib Tosylate Sorafenib Tosylate, Recombinant Interferon Alfa-2b Total
Hide Arm/Group Description Arm I: Oral Sorafenib 400 mg twice daily on days 1-28. Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28. Total of all reporting groups
Overall Number of Baseline Participants 40 40 80
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 80 participants
62.4
(45 to 83)
60.7
(43 to 81)
62.0
(43 to 83)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Female
8
  20.0%
11
  27.5%
19
  23.8%
Male
32
  80.0%
29
  72.5%
61
  76.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 40 participants 40 participants 80 participants
40 40 80
ECOG (Performance Status)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
0 25 25 50
1 15 15 30
[1]
Measure Description: Eastern Cooperative Oncology Group (ECOG) Scale used to assess how a participant's disease is progressing, assess how the disease affects the daily living abilities of the participant, and determine appropriate treatment and prognosis. Scale runs from 0 to 5, with 0 denoting perfect health and 5 death.
Nephrectomy   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Yes 40 39 79
No 0 1 1
[1]
Measure Description: Number of participants who had nephrectomy
Memorial Sloan–Kettering Cancer Center (MSKCC) Prognostic Risk   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Low 21 20 41
Intermediate 19 18 37
Poor 0 2 2
[1]
Measure Description: MSKCC risk system stratifies participants poor, intermediate and favorable-risk categories based on number of adverse clinical/laboratory parameters present. Poor prognostic factors include Karnofsky performance status <80, time from diagnosis to treatment <12 months, serum lactate dehydrogenase >1.5-times upper limit of normal, corrected serum calcium >10.0 mg/dl & hemoglobin <lower limit of normal. Favorable-risk group have no poor prognostic factors, intermediate-risk category have 1 or 2 adverse prognostic factors, & participants with poor-risk have >2 poor prognostic factors.
Number of Metastatic Sites  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
One 13 14 27
Two 17 20 37
Three or More 10 6 16
Sites of Metastatic Disease   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 80 participants
Lung 33 30 63
Lymph Nodes 20 15 35
Liver 3 5 8
Bone 5 6 11
Other 19 19 38
[1]
Measure Description: Number of participants with metastatic tumor sites in the noted locations for each study arm population.
1.Primary Outcome
Title Objective Response Rate (ORR) Evaluated Using Response Evaluation Criteria in Solid Tumors (RECIST)
Hide Description ORR defined as participants with Complete Response (CR) and Partial Response (PR) as defined by RECIST criteria: Complete Response (CR): Disappearance all target lesions. Partial Response (PR): >30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): >20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Radiologic testing for progressive disease repeated every 8 weeks.
Time Frame Tumor restaging performed at 8 weeks following baseline, responding or stable participants restaged at 8 week intervals, up to 12 months.
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis performed for the intent-to-treat population.
Arm/Group Title Sorafenib Tosylate Sorafenib Tosylate, Recombinant Interferon Alfa-2b
Hide Arm/Group Description:
Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
30
(16.56 to 46.53)
25
(12.69 to 41.20)
2.Secondary Outcome
Title Selected Grade 3-4 Adverse Events Using NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0
Hide Description Adverse events graded using the CTCAE version 4.0 tabulated by treatment arm within either toxicity grade for the treatment period. Treatment-related toxicity (acute and cumulative) performed every 8 weeks during the first year.
Time Frame Up to 12 months of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included in adverse event reporting per intent to treat analysis.
Arm/Group Title Sorafenib Tosylate Sorafenib Tosylate, Recombinant Interferon Alfa-2b
Hide Arm/Group Description:
Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: participants
Fatigue 10 13
Diarrhea 13 8
Hand-Foot Syndrome 10 7
Hyperuricemia 12 3
Hyperamylasemia or Lipasemia 5 4
Dyspnea 4 4
Hypophosphatemia 3 5
Neutropenia 0 6
Hypertension 2 3
Nausea and vomiting 1 3
Rash/Desquamation 2 2
Proteinuria 1 2
Syncope (Fainting) 0 3
Weight Loss 0 3
Transaminitis 0 3
Hyponatremia 2 1
Nonneutropenic Infection 2 0
Sensory Neuropathy 1 1
Cardiac Ischemia/Infarction 1 0
Appendicitis 1 0
Pancreatitis 1 0
Adrenal Insufficiency 0 1
Reversible Posterior Leukonencephalopathy 0 1
Small Bowel Obstruction 1 0
Pneumonitis 1 0
3.Secondary Outcome
Title Progression-free Survival
Hide Description Progression free survival (PFS) is defined as the time interval from the start of protocol therapy to death or disease progression.
Time Frame From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included per intent to treat analysis.
Arm/Group Title Sorafenib Tosylate Sorafenib Tosylate, Recombinant Interferon Alfa-2b
Hide Arm/Group Description:
Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
Overall Number of Participants Analyzed 40 40
Median (95% Confidence Interval)
Unit of Measure: Months
7.39
(5.52 to 9.20)
7.56
(5.19 to 11.07)
4.Secondary Outcome
Title Median Overall Survival (OS)
Hide Description Overall survival defined as the time interval from the start of protocol therapy to death or date of last follow-up if alive.
Time Frame From the start of protocol therapy to death or date of last follow-up, up to 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who die of unrelated cause during therapy or are lost to follow-up were censored. Median OS was not reached in Arm 1: Sorafenib as subjects experienced different events that made further follow-up impossible i.e. disease complications, death or lost to follow-up so overall survival data was not attainable.
Arm/Group Title Sorafenib Tosylate Sorafenib Tosylate, Recombinant Interferon Alfa-2b
Hide Arm/Group Description:
Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
Overall Number of Participants Analyzed 40 40
Median (95% Confidence Interval)
Unit of Measure: Months
NA [1] 
(NA to NA)
27.04 [2] 
(22.31 to NA)
[1]
Median OS nor limits attained due to censoring of participants who died of unrelated cause during therapy or were lost to follow-up.
[2]
Upper limit not attained due to censoring of participants who died of unrelated cause during therapy or were lost to follow-up.
5.Secondary Outcome
Title Duration of Response for Participants With Stable Disease (N=37) Following Treatment
Hide Description Duration of response for participants with disease stabilization following treatment as measured from the date response is confirmed to the date of disease progression, first assessed up to 8 weeks (2 cycles) following start of treatment. The duration of a Stable Disease (SD) response is measured from the time measurement criteria are met for that specific SD response until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Repeat radiologic studies (CT, MRI, Chest x-ray and bone scan as indicated) to evaluate disease progression or response every 8 weeks.
Time Frame From the date response is confirmed to the date of disease progression, up to 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Combined analysis reflects overall stable disease duration e.g. duration of benefit for stable disease cases without being affected by the median duration not attainable for the separate arms; 37 participants in the two arms met "Stable Disease" criteria: 17 in Sorafenib alone (Arm I) and 20 in the Sorafenib Plus Interferon group (Arm II).
Arm/Group Title Sorafenib Tosylate or Sorafenib Plus Interferon
Hide Arm/Group Description:
Arm I: Oral Sorafenib 400 mg twice daily on days 1-28 and Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
Overall Number of Participants Analyzed 37
Median (95% Confidence Interval)
Unit of Measure: Months
5.7
(3.7 to 8.4)
6.Post-Hoc Outcome
Title Best Overall Response for Participants
Hide Description Best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The participant's best response assignment will depend on the achievement of both measurement and confirmation criteria as defined by RECIST: Complete Response (CR): Disappearance all target lesions. Partial Response (PR): >30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD. Progressive Disease (PD): >20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of one or more new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started. Radiologic testing for progressive disease repeated every 8 weeks.
Time Frame From the date response is confirmed to the date of disease progression, first assessed 2 months (8 weeks) following start of treatment and reassessed up to 36 months (on average reassessed 12 months or less).
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were included per intent to treat analysis.
Arm/Group Title Sorafenib Tosylate Sorafenib Tosylate, Recombinant Interferon Alfa-2b
Hide Arm/Group Description:
Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
Overall Number of Participants Analyzed 40 40
Measure Type: Number
Unit of Measure: participants
Complete Response (CR) 1 0
Partial Response (PR) 11 10
Stable Disease (SD) 17 20
Progressive Disease (PD) 6 7
Inevaluable 5 3
Time Frame Adverse event reporting from time of first intervention to follow up 30 days beyond last intervention. Overall study period: June 2005 to August 2013.
Adverse Event Reporting Description Revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 utilized for AE reporting until September 30, 2010. CTCAE version 4.0 utilized beginning October 1, 2010.
 
Arm/Group Title Sorafenib Tosylate Sorafenib Tosylate, Recombinant Interferon Alfa-2b
Hide Arm/Group Description Arm I: Oral Sorafenib 400 mg twice daily on days 1-28. Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
All-Cause Mortality
Sorafenib Tosylate Sorafenib Tosylate, Recombinant Interferon Alfa-2b
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sorafenib Tosylate Sorafenib Tosylate, Recombinant Interferon Alfa-2b
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/40 (72.50%)      30/40 (75.00%)    
General disorders     
Death  1  27/40 (67.50%)  27 29/40 (72.50%)  29
Hepatobiliary disorders     
Pancreatitis  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Infections and infestations     
Appendicitis  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Metabolism and nutrition disorders     
Hyperuricemia  2  6/40 (15.00%)  12 2/40 (5.00%)  2
Serum amylase increased  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Lipase Increased  2  0/40 (0.00%)  0 1/40 (2.50%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sorafenib Tosylate Sorafenib Tosylate, Recombinant Interferon Alfa-2b
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/40 (100.00%)      40/40 (100.00%)    
Blood and lymphatic system disorders     
Anemia  2  19/40 (47.50%)  30 30/40 (75.00%)  60
Blood bilirubin increased  2  9/40 (22.50%)  17 11/40 (27.50%)  17
Lymphocyte count decreased  2  4/40 (10.00%)  9 12/40 (30.00%)  51
Platelet count decreased  2  2/40 (5.00%)  2 21/40 (52.50%)  39
Cardiac disorders     
Conduction disorder  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Hypertension  2  16/40 (40.00%)  26 10/40 (25.00%)  14
Hypotension  2  1/40 (2.50%)  1 2/40 (5.00%)  3
Myocardial infarction  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Palpitations  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Sinus tachycardia  2  0/40 (0.00%)  0 1/40 (2.50%)  1
Supraventricular tachycardia  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Vascular disorders - (Other)  2  0/40 (0.00%)  0 2/40 (5.00%)  5
Ear and labyrinth disorders     
Otitis media  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Tinnitus  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Endocrine disorders     
Adrenal insufficiency  2  0/40 (0.00%)  0 1/40 (2.50%)  1
Eye disorders     
Blurred vision  2  3/40 (7.50%)  3 5/40 (12.50%)  9
Extraocular muscle paresis  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Eye disorders  2  1/40 (2.50%)  1 1/40 (2.50%)  4
Eye pain  2  1/40 (2.50%)  1 1/40 (2.50%)  1
Glaucoma  2  1/40 (2.50%)  1 1/40 (2.50%)  1
Watering eyes  2  2/40 (5.00%)  2 0/40 (0.00%)  0
Gastrointestinal disorders     
Abdominal distension  1  4/40 (10.00%)  4 4/40 (10.00%)  5
Abdominal pain  2  7/40 (17.50%)  15 10/40 (25.00%)  12
Anorexia  2  9/40 (22.50%)  10 10/40 (25.00%)  17
Constipation  2  4/40 (10.00%)  9 5/40 (12.50%)  11
Diarrhea  2  33/40 (82.50%)  375 32/40 (80.00%)  382
Dysgeusia  2  4/40 (10.00%)  5 7/40 (17.50%)  7
Dyspepsia  2  3/40 (7.50%)  4 2/40 (5.00%)  2
Flatulence  2  7/40 (17.50%)  13 7/40 (17.50%)  14
Gastritis  2  2/40 (5.00%)  2 0/40 (0.00%)  0
Gastrointestinal disorders  2  1/40 (2.50%)  1 2/40 (5.00%)  2
Gastrointestinal pain  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Hemorrhoids  2  0/40 (0.00%)  0 3/40 (7.50%)  14
Mucositis oral  2  14/40 (35.00%)  77 18/40 (45.00%)  39
Nausea  2  18/40 (45.00%)  57 24/40 (60.00%)  60
Oral pain  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Rectal pain  2  0/40 (0.00%)  0 1/40 (2.50%)  1
Small intestinal obstruction  2  1/40 (2.50%)  1 1/40 (2.50%)  1
Sore throat  2  0/40 (0.00%)  0 1/40 (2.50%)  1
Stomach pain  2  1/40 (2.50%)  5 1/40 (2.50%)  1
Toothache  2  1/40 (2.50%)  2 1/40 (2.50%)  1
Vomiting  2  11/40 (27.50%)  42 14/40 (35.00%)  34
General disorders     
Chills  2  0/40 (0.00%)  0 2/40 (5.00%)  2
Edema limbs  2  4/40 (10.00%)  4 2/40 (5.00%)  2
Edema trunk  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Fatigue  2  33/40 (82.50%)  184 36/40 (90.00%)  247
Insomnia  2  0/40 (0.00%)  0 1/40 (2.50%)  1
Non-cardiac chest pain  2  3/40 (7.50%)  7 3/40 (7.50%)  4
Pain  2  7/40 (17.50%)  17 5/40 (12.50%)  13
Pelvic pain  2  0/40 (0.00%)  0 1/40 (2.50%)  3
Weight loss  2  15/40 (37.50%)  27 21/40 (52.50%)  42
Hepatobiliary disorders     
Pancreatitis  2  0/40 (0.00%)  0 0/40 (0.00%)  0
Immune system disorders     
Allergic reaction  2  0/40 (0.00%)  0 1/40 (2.50%)  1
Allergic rhinitis  2  2/40 (5.00%)  3 3/40 (7.50%)  5
Infections and infestations     
Appendicitis  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Infections and infestations - (Other)  2  5/40 (12.50%)  6 3/40 (7.50%)  3
Pneumonitis  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Injury, poisoning and procedural complications     
Injection site reaction  2  0/40 (0.00%)  0 5/40 (12.50%)  8
Investigations     
Carbon monoxide diffusing capacity decreased  2  0/40 (0.00%)  0 1/40 (2.50%)  1
Fever  2  7/40 (17.50%)  17 10/40 (25.00%)  20
Flu like symptoms  2  0/40 (0.00%)  0 3/40 (7.50%)  6
Metabolism and nutrition disorders     
Acidosis  2  0/40 (0.00%)  0 1/40 (2.50%)  1
Alanine aminotransferase increased  2  7/40 (17.50%)  10 23/40 (57.50%)  41
Alkaline phosphatase increased  2  13/40 (32.50%)  19 11/40 (27.50%)  14
Aspartate aminotransferase increased  2  22/40 (55.00%)  33 29/40 (72.50%)  55
Cholesterol high  2  15/40 (37.50%)  25 7/40 (17.50%)  12
Creatinine increased  2  10/40 (25.00%)  18 8/40 (20.00%)  15
Dehydration  2  0/40 (0.00%)  0 1/40 (2.50%)  1
Gait disturbance  2  0/40 (0.00%)  0 1/40 (2.50%)  1
Hemoglobinuria  2  2/40 (5.00%)  2 1/40 (2.50%)  1
Hypercalcemia  2  2/40 (5.00%)  2 2/40 (5.00%)  2
Hyperglycemia  2  22/40 (55.00%)  42 17/40 (42.50%)  47
Hyperkalemia  2  10/40 (25.00%)  16 8/40 (20.00%)  12
Hypertriglyceridemia  2  20/40 (50.00%)  20 21/40 (52.50%)  49
Hyperuricemia  2  24/40 (60.00%)  66 19/40 (47.50%)  37
Hypoalbuminemia  2  4/40 (10.00%)  5 6/40 (15.00%)  9
Hypocalcemia  2  2/40 (5.00%)  2 14/40 (35.00%)  37
Hypoglycemia  2  22/40 (55.00%)  42 3/40 (7.50%)  8
Hypokalemia  2  10/40 (25.00%)  16 6/40 (15.00%)  9
Hypomagnesemia  2  17/40 (42.50%)  37 21/40 (52.50%)  42
Hyponatremia  2  5/40 (12.50%)  8 4/40 (10.00%)  7
Hypophosphatemia  2  20/40 (50.00%)  36 20/40 (50.00%)  49
Lipase increased  2  5/40 (12.50%)  9 5/40 (12.50%)  5
Neutrophil count decreased  2  0/40 (0.00%)  0 18/40 (45.00%)  47
Serum amylase increased  2  3/40 (7.50%)  3 4/40 (10.00%)  4
White blood cell decreased  2  3/40 (7.50%)  4 27/40 (67.50%)  63
Musculoskeletal and connective tissue disorders     
Arthralgia  2  8/40 (20.00%)  21 7/40 (17.50%)  23
Arthritis  2  2/40 (5.00%)  3 2/40 (5.00%)  2
Back pain  2  11/40 (27.50%)  20 13/40 (32.50%)  42
Bone pain  2  6/40 (15.00%)  16 6/40 (15.00%)  20
Chest wall pain  2  0/40 (0.00%)  0 1/40 (2.50%)  2
Fracture  2  0/40 (0.00%)  0 1/40 (2.50%)  1
Joint range of motion decreased  2  0/40 (0.00%)  0 1/40 (2.50%)  2
Myalgia  2  10/40 (25.00%)  20 8/40 (20.00%)  15
Neck pain  2  2/40 (5.00%)  6 1/40 (2.50%)  1
Pain in extremity  2  12/40 (30.00%)  35 14/40 (35.00%)  39
Tremor  2  0/40 (0.00%)  0 1/40 (2.50%)  2
Nervous system disorders     
Dizziness  2  2/40 (5.00%)  3 0/40 (0.00%)  0
Headache  2  3/40 (7.50%)  8 5/40 (12.50%)  6
Memory impairment  2  0/40 (0.00%)  0 1/40 (2.50%)  1
Nervous system disorders - (Other)  2  0/40 (0.00%)  0 1/40 (2.50%)  1
Peripheral motor neuropathy  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Peripheral sensory neuropathy  2  10/40 (25.00%)  20 14/40 (35.00%)  42
Syncope  2  0/40 (0.00%)  0 3/40 (7.50%)  3
Psychiatric disorders     
Agitation  2  0/40 (0.00%)  0 1/40 (2.50%)  1
Depression  2  3/40 (7.50%)  4 7/40 (17.50%)  7
Renal and urinary disorders     
Bladder infection  2  2/40 (5.00%)  2 0/40 (0.00%)  0
Bladder spasm  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Proteinuria  2  16/40 (40.00%)  31 24/40 (60.00%)  48
Renal and urinary disorders - (Other)  2  1/40 (2.50%)  1 1/40 (2.50%)  2
Urinary frequency  2  0/40 (0.00%)  0 1/40 (2.50%)  2
Reproductive system and breast disorders     
Erectile dysfunction  2  3/40 (7.50%)  3 1/40 (2.50%)  1
Reproductive system and breast disorders - (Other)  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Scrotal pain  2  1/40 (2.50%)  2 0/40 (0.00%)  0
Testicular pain  2  0/40 (0.00%)  0 1/40 (2.50%)  2
Respiratory, thoracic and mediastinal disorders     
Bronchospasm  2  0/40 (0.00%)  0 1/40 (2.50%)  1
Cough  2  7/40 (17.50%)  18 11/40 (27.50%)  19
Dyspnea  2  16/40 (40.00%)  33 20/40 (50.00%)  64
Epistaxis  2  1/40 (2.50%)  8 0/40 (0.00%)  0
Hiccups  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Hypoxia  2  0/40 (0.00%)  0 1/40 (2.50%)  1
Lung infection  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Pharyngolaryngeal pain  2  1/40 (2.50%)  1 1/40 (2.50%)  2
Pleural effusion  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - (Other)  2  2/40 (5.00%)  3 1/40 (2.50%)  1
Sinus pain  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Upper respiratory infection  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Voice alteration  2  1/40 (2.50%)  1 3/40 (7.50%)  3
Skin and subcutaneous tissue disorders     
Alopecia  2  22/40 (55.00%)  22 20/40 (50.00%)  20
Dry skin  2  27/40 (67.50%)  50 22/40 (55.00%)  50
Flushing  2  1/40 (2.50%)  1 1/40 (2.50%)  1
Hyperhidrosis  2  4/40 (10.00%)  6 1/40 (2.50%)  1
Pain of skin  2  0/40 (0.00%)  0 1/40 (2.50%)  2
Palmar-plantar erythrodysesthesia syndrome  2  32/40 (80.00%)  77 31/40 (77.50%)  109
Pruritus  2  8/40 (20.00%)  8 4/40 (10.00%)  6
Rash acneiform  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Rash maculo-papular  2  30/40 (75.00%)  63 26/40 (65.00%)  62
Skin and subcutaneous tissue disorders - (Other)  2  11/40 (27.50%)  18 12/40 (30.00%)  25
Skin infection  2  0/40 (0.00%)  0 1/40 (2.50%)  1
Skin ulceration  2  0/40 (0.00%)  0 3/40 (7.50%)  3
Urticaria  2  1/40 (2.50%)  1 0/40 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
2
Term from vocabulary, CTCAE (4.0)
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
Layout table for Results Point of Contact information
Name/Title: Eric Jonasch, MD/Associate Professor, Genitourinary Medical Oncology
Organization: University of Texas (UT) MD Anderson Cancer Center
Phone: 713-792-2830
EMail: CR_Study_Registration@mdanderson.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00126594     History of Changes
Other Study ID Numbers: NCI-2012-02910
NCI-2012-02910 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000437796
2004-0526 ( Other Identifier: M D Anderson Cancer Center )
6629 ( Other Identifier: CTEP )
N01CM62202 ( U.S. NIH Grant/Contract )
P30CA016672 ( U.S. NIH Grant/Contract )
First Submitted: August 2, 2005
First Posted: August 4, 2005
Results First Submitted: February 9, 2016
Results First Posted: September 16, 2016
Last Update Posted: September 16, 2016