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Sorafenib in Treating Patients With Metastatic Kidney Cancer That Has Not Responded to Sunitinib or Bevacizumab

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ClinicalTrials.gov Identifier: NCT00866320
Recruitment Status : Completed
First Posted : March 20, 2009
Results First Posted : February 1, 2012
Last Update Posted : July 23, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Kidney Cancer
Intervention Drug: sorafenib tosylate
Enrollment 49
Recruitment Details This is a multiple site study. Patients were recruited 2/2006-4/2008 from medical hospitals in Cleveland, Ohio and Dallas, Texas
Pre-assignment Details  
Arm/Group Title Sorafenib
Hide Arm/Group Description Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
Period Title: Overall Study
Started 49
Completed 43 [1]
Not Completed 6
Reason Not Completed
Withdrawal by Subject             4
Death             2
[1]
All patients that received treatment were analyzed.
Arm/Group Title Sorafenib
Hide Arm/Group Description Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
Overall Number of Baseline Participants 49
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants
63.2  (8.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Female
36
  73.5%
Male
13
  26.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 49 participants
49
1.Primary Outcome
Title Tumor Burden Reduction Rate (TBRR)
Hide Description The primary endpoint of the study is defined as the percentage of patients who experience larger than or equal to 5% reduction in tumor burden as measured by RECIST-defined target lesions without progression of non-target lesions or the appearance of any new lesions, confirmed at least 4 weeks after first documentation. RECIST criteria will be used for the purpose of designating target lesions, calculating total tumor burden (the sum of the unidimensional measurement of target lesions) and defining disease progression.Additional RECIST-defined partial or complete responses will be recorded.
Time Frame at 8 weeks (2cycles of treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who started treatment
Arm/Group Title Sorafenib
Hide Arm/Group Description:
Patients receive sorafenib twice a day until disease progression or toxicity.
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: percentage of patients
Achieved at least 5% tumor reduction 30
Did not achieve at least 5% tumor reduction 70
2.Secondary Outcome
Title Overall Survival
Hide Description Overall survival measured in months and summarized using the Kaplan-Meier method. This will be calculated from the date of registration on-study to the dates of documented evidence of progression and death, respectively.
Time Frame followed until progression or death for approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who started treatment
Arm/Group Title Sorafenib
Hide Arm/Group Description:
Patients receive sorafenib twice a day until disease progression or toxicity.
Overall Number of Participants Analyzed 47
Median (95% Confidence Interval)
Unit of Measure: months
16
(7.6 to 32.3)
3.Secondary Outcome
Title Time to Progression
Hide Description

Time to objective progression will be measured from the start of treatment until the criteria for RECIST-defined progression are met, taking as reference the smallest measurements recorded since the treatment started, including baseline.

Progression-free survival measured in months and summarized using the Kaplan-Meier method.

Time Frame followed to progression for approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who started treatment
Arm/Group Title Sorafenib
Hide Arm/Group Description:
Sorafenib twice a day until progression or toxicity
Overall Number of Participants Analyzed 47
Median (95% Confidence Interval)
Unit of Measure: months
4.4
(3.6 to 5.9)
4.Secondary Outcome
Title Duration of Overall Response (Tumor Burden Reduction)
Hide Description Measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.
Time Frame followed for overall response for approximately 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who achieved at least 5% tumor reduction
Arm/Group Title Sorafenib
Hide Arm/Group Description:
Patients receive Sorafenib twice a day until disease progression or toxicity
Overall Number of Participants Analyzed 14
Median (95% Confidence Interval)
Unit of Measure: months
7.1
(2.1 to 9.2)
Time Frame Adverse events collected from the start of treatment to the end of the study for a period of 3 years and 8 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sorafenib
Hide Arm/Group Description Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
All-Cause Mortality
Sorafenib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sorafenib
Affected / at Risk (%)
Total   4/47 (8.51%) 
Cardiac disorders   
Thrombosis/embolism  1  1/47 (2.13%) 
Gastrointestinal disorders   
Anorexia  1  1/47 (2.13%) 
Constipation  1  1/47 (2.13%) 
Nausea  1  1/47 (2.13%) 
General disorders   
Constitutional Symptoms  1  1/47 (2.13%) 
Pain  1  1/47 (2.13%) 
Metabolism and nutrition disorders   
Metabolic/Laboratory  1  1/47 (2.13%) 
Musculoskeletal and connective tissue disorders   
Myalgia (muscle pain)  1  1/47 (2.13%) 
Skin and subcutaneous tissue disorders   
Hand-Foot Skin Reaction  1  1/47 (2.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sorafenib
Affected / at Risk (%)
Total   41/47 (87.23%) 
Blood and lymphatic system disorders   
Hemoglobin  1  4/47 (8.51%) 
Endocrine disorders   
Hypothyroidism  1  4/47 (8.51%) 
Gastrointestinal disorders   
Anorexia  1  17/47 (36.17%) 
Constipation  1  5/47 (10.64%) 
Diarrhea  1 [1]  25/47 (53.19%) 
Taste Disturbance (dysgeusia)  1  7/47 (14.89%) 
Nausea  1  13/47 (27.66%) 
Stomatitis/pharyngitis  1 [2]  13/47 (27.66%) 
Vomiting  1  6/47 (12.77%) 
Gastrointestinal-other  1  11/47 (23.40%) 
General disorders   
Edema  1  4/47 (8.51%) 
Fatigue  1 [3]  25/47 (53.19%) 
Fever  1 [4]  3/47 (6.38%) 
Rigors, Chills  1  3/47 (6.38%) 
Weight Loss  1  10/47 (21.28%) 
General Disorders-other  1  3/47 (6.38%) 
Pain-other  1  9/47 (19.15%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal-other  1  4/47 (8.51%) 
Arthralgia  1 [5]  4/47 (8.51%) 
Myalgia (muscle pain)  1  5/47 (10.64%) 
Nervous system disorders   
Headache  1  4/47 (8.51%) 
Reproductive system and breast disorders   
Voice Changes/stridor/larynx  1 [6]  4/47 (8.51%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  4/47 (8.51%) 
Dyspnea  1 [7]  3/47 (6.38%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  12/47 (25.53%) 
Rash/desquamation  1  14/47 (29.79%) 
Dry Skin  1  6/47 (12.77%) 
Hand-Foot Skin Reaction  1  28/47 (59.57%) 
Dermatology/Skin-other  1  14/47 (29.79%) 
Vascular disorders   
Hypertension  1  16/47 (34.04%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (2.0)
[1]
patients without colostomy
[2]
oral/pharyngeal mucositis
[3]
Lethargy, malaise, asthenia
[4]
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)
[5]
Joint pain
[6]
hoarseness, loss of voice, laryngitis
[7]
shortness of breath
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Brian Rini
Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Phone: 216-444-9567
EMail: rinib2@ccf.org
Layout table for additonal information
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00866320     History of Changes
Other Study ID Numbers: CASE11805
P30CA043703 ( U.S. NIH Grant/Contract )
CASE11805 ( Other Identifier: Case Comprehensive Cancer Center )
05-167 ( Other Identifier: Cleveland Clinic IRB )
First Submitted: March 19, 2009
First Posted: March 20, 2009
Results First Submitted: December 27, 2011
Results First Posted: February 1, 2012
Last Update Posted: July 23, 2014