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Trial record 1 of 58 for:    "Clear Cell Renal Cell Carcinoma" | "Protein Kinase Inhibitors"
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Sorafenib in Treating Patients With Locally Advanced or Metastatic Kidney Cancer

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ClinicalTrials.gov Identifier: NCT00727532
Recruitment Status : Terminated (Low Accrual)
First Posted : August 4, 2008
Results First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Northwestern University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hereditary Clear Cell Renal Cell Carcinoma
Kidney Cancer
Intervention Drug: Sorafenib
Enrollment 9
Recruitment Details Study was open to enrollment at Northwestern University beginning June 2008, and closed to enrollment in September 2012.
Pre-assignment Details  
Arm/Group Title Sorafenib
Hide Arm/Group Description

Sorafenib 400mg orally twice daily on days 1-28

sorafenib tosylate: 400mg by mouth twice daily for 28 consecutive days

diffusion-weighted magnetic resonance imaging: At baseline and just prior to surgery after sorafenib treatment

Period Title: Overall Study
Started 9
Completed 7
Not Completed 2
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             1
Arm/Group Title Sorafenib
Hide Arm/Group Description Sorafenib 400mg orally twice daily on days 1-28
Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
0
   0.0%
Between 18 and 65 years
5
  55.6%
>=65 years
4
  44.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
4
  44.4%
Male
5
  55.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants
9
Renal cell carcinoma Clinical Staging   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants
T1>3cm 0
T2 0
T3 8
T4 1
[1]
Measure Description: Participants must have bulky (T1>3cm,any T2, T3,orT4) renal cell carcinoma undergoing nephrectomy.Staging defined as:T1>3cm: Tumor ≤7cm in greatest dimension but >3cm, limited to the kidney;T2:Tumor >7cm, limited to the kidney;T3:Tumor extends into major veins but not into the ipsilateral adrenal gland & not beyond Gerota fascia (the fibrous layer that surrounds the kidney & nearby fatty tissue);T4:Tumor invades beyond Gerota fascia(including contiguous extension into ipsilateral adrenal gland).The higher the number after the T, the larger the tumor or more it has grown into nearby tissues.
1.Primary Outcome
Title Percentage Change in Difference in Apparent Diffusion Coefficient Between Baseline and Week 5
Hide Description Mean Difference in Apparent Diffusion Coefficient [Time Frame: Baseline and Week 5] To assess whether changes in the apparent diffusion coefficient (ADC) during neoadjuvant sorafenib treatment are detectable in locally advanced or metastatic kidney cancer. The ADC value will be calculated at baseline (within 28 days of initiating sorafenib) and Week 5, and the mean difference will be calculated. The percent change between this mean difference is reported. Week 5 ADC value minus baseline ADC value/divided by baseline ADC value was calculated for each participant. Apparent diffusion coefficient (ADC), obtained by measuring diffusion values at magnetic resonance imaging (MRI), is a measure of water mobility. Lower values correspond to tumor and higher values are consistent with cysts. With sorafenib therapy, the amount of free water may increase in a lesion due to necrosis, and as a result the ADC may increase in value.
Time Frame Baseline and week 5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sorafenib
Hide Arm/Group Description:

Sorafenib 400mg orally twice daily on days 1-28

sorafenib tosylate: 400mg by mouth twice daily for 28 consecutive days

diffusion-weighted magnetic resonance imaging: At baseline and just prior to surgery after sorafenib treatment

Overall Number of Participants Analyzed 7
Mean (Full Range)
Unit of Measure: Percent change
-7.57
(-59.00 to 49.40)
2.Primary Outcome
Title Change in Tumor Size From Baseline to Approximately 29-34 Days After Completion of Neoadjuvant Sorafenib Treatment
Hide Description Tumors were measured at baseline and approximately 29-34 days after completion of neoadjuvant treatment with sorafenib (just prior to surgery). Tumors were assessed by RECIST response criteria.
Time Frame Just prior to study week 5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sorafenib
Hide Arm/Group Description:

Sorafenib 400mg orally twice daily on days 1-28

sorafenib tosylate: 400mg by mouth twice daily for 28 consecutive days

diffusion-weighted magnetic resonance imaging: At baseline and just prior to surgery after sorafenib treatment

Overall Number of Participants Analyzed 7
Median (Full Range)
Unit of Measure: percent change
-5.34
(-15.3 to 7.2)
3.Post-Hoc Outcome
Title Percentage Change of Necrosis From Baseline to Surgery
Hide Description Changes in MRI will be correlated with findings of necrosis. Amount of necrosis will be measured at baseline and at time of surgery. Percentage change for necrosis will be calculated from baseline and time of surgery.
Time Frame At time of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sorafenib
Hide Arm/Group Description:

Sorafenib 400mg orally twice daily on days 1-28

sorafenib tosylate: 400mg by mouth twice daily for 28 consecutive days

diffusion-weighted magnetic resonance imaging: At baseline and just prior to surgery after sorafenib treatment

Overall Number of Participants Analyzed 7
Mean (Full Range)
Unit of Measure: Percentage change
20.13
(-38.32 to 92.92)
Time Frame Adverse events assessed for 28 days prior to surgical resection
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sorafenib
Hide Arm/Group Description

Sorafenib 400mg orally twice daily on days 1-28

sorafenib tosylate: 400mg by mouth twice daily for 28 consecutive days

diffusion-weighted magnetic resonance imaging: At baseline and just prior to surgery after sorafenib treatment

All-Cause Mortality
Sorafenib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sorafenib
Affected / at Risk (%) # Events
Total   1/9 (11.11%)    
Hepatobiliary disorders   
Pancreatitis  1  1/9 (11.11%)  1
Skin and subcutaneous tissue disorders   
Hand-Foot Skin Reaction  1  1/9 (11.11%)  1
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 0%
Sorafenib
Affected / at Risk (%) # Events
Total   9/9 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  1/9 (11.11%) 
Gastrointestinal disorders   
Mucositis/Stomatitis (functional symptomatic) - Oral Cavity  1  2/9 (22.22%) 
Nausea  1  3/9 (33.33%) 
Diarrhea  1  2/9 (22.22%) 
Anorexia  1  1/9 (11.11%) 
General disorders   
Pain  1  1/9 (11.11%) 
Fatigue  1  2/9 (22.22%) 
Fever  1  2/9 (22.22%) 
Investigations   
Elevated Transaminitis  1 [1]  2/9 (22.22%) 
Elevated creatinine  1  2/9 (22.22%) 
Lymphopenia  1  1/9 (11.11%) 
Metabolism and nutrition disorders   
Hypocalcemia  1  1/9 (11.11%) 
Hypokalemia  1  1/9 (11.11%) 
Hyponatremia  1  3/9 (33.33%) 
Nervous system disorders   
Peripheral Sensory Neuropathy  1  1/9 (11.11%) 
Skin and subcutaneous tissue disorders   
Rash  1  5/9 (55.56%) 
Hand-Foot Skin reaction  1  4/9 (44.44%) 
Dry Skin  1  1/9 (11.11%) 
Alopecia  1  1/9 (11.11%) 
Pruritis  1  1/9 (11.11%) 
Vascular disorders   
Hypertension  1  1/9 (11.11%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
alanine aminotransferase, aspartate aminotransferase, or both
The trial did not reach the original goal of 10 subjects. Only 9 out of 10 patients had been enrolled, with no accrual for a period of more than 1 year. Therefore it was administratively closed by the Data Monitoring Committee.
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: Results Entry Administrator
Organization: Northwestern University
Phone: 312-695-1301
EMail: croqualityassurance@northwestern.edu
Layout table for additonal information
Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT00727532     History of Changes
Other Study ID Numbers: NU 07U1
P30CA060553 ( U.S. NIH Grant/Contract )
NU-IRB-STU00003123 ( Other Identifier: Northwestern University IRB )
First Submitted: August 1, 2008
First Posted: August 4, 2008
Results First Submitted: April 7, 2016
Results First Posted: May 3, 2019
Last Update Posted: May 3, 2019