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Sorafenib in Treating Patients Who Are Undergoing Surgery for Metastatic Kidney Cancer

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ClinicalTrials.gov Identifier: NCT00126659
Recruitment Status : Terminated
First Posted : August 4, 2005
Results First Posted : December 31, 2012
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Clear Cell Renal Cell Carcinoma
Recurrent Renal Cell Cancer
Stage IV Renal Cell Cancer
Interventions Procedure: therapeutic conventional surgery
Drug: sorafenib tosylate
Other: laboratory biomarker analysis
Enrollment 10
Recruitment Details Recruitment Period: January 11, 2006 to July 12, 2007. All recruitment done at UT MD Anderson Cancer Center.
Pre-assignment Details This trial was run at the same time as a competing trial and suffered from poor accrual. For that reason it was closed.
Arm/Group Title Cytoreductive Nephrectomy Day 0 Sorafenib + Cytoreductive Nephrectomy Day 8 Sorafenib + Cytoreductive Nephrectomy Day 29
Hide Arm/Group Description Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day. Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib
Period Title: Overall Study
Started 3 3 4
Completed 3 3 2
Not Completed 0 0 2
Reason Not Completed
Adverse Event             0             0             2
Arm/Group Title Cytoreductive Nephrectomy Day 0 Sorafenib + Cytoreductive Nephrectomy Day 8 Sorafenib + Cytoreductive Nephrectomy Day 29 Total
Hide Arm/Group Description Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day. Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib Total of all reporting groups
Overall Number of Baseline Participants 3 3 4 10
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 4 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  33.3%
1
  33.3%
2
  50.0%
4
  40.0%
>=65 years
2
  66.7%
2
  66.7%
2
  50.0%
6
  60.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 4 participants 10 participants
Female
3
 100.0%
1
  33.3%
1
  25.0%
5
  50.0%
Male
0
   0.0%
2
  66.7%
3
  75.0%
5
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants 3 participants 4 participants 10 participants
3 3 4 10
1.Primary Outcome
Title Efficacy of BAY 43-9006 by Evaluating Response Rate
Hide Description

Response rate (participants with response/total number participants) where number of participants with response evaluated using international criteria proposed by (RECIST) Committee of: Complete Response: 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 1 or > new lesions; Stable Disease:

Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, reference smallest sum LD since treatment started.

Time Frame Every 2 weeks during 4 week cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Unable to assess response due to small sample size.
Arm/Group Title Cytoreductive Nephrectomy Day 0 Sorafenib + Cytoreductive Nephrectomy Day 8 Sorafenib + Cytoreductive Nephrectomy Day 29
Hide Arm/Group Description:
Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day.
Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib
Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Other Pre-specified Outcome
Title Duration of Overall Response
Hide Description Duration of overall response is measured from the time measurement criteria are met for Complete Response or Partial Response (whichever is first recorded) 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), measured in days.
Time Frame Following 10 weeks of treatment, followed every 2 weeks or until disease progression
Outcome Measure Data Not Reported
3.Other Pre-specified Outcome
Title Overall Survival
Hide Description The number of participants surviving from baseline (treatment) to death due to any cause measured in days.
Time Frame Up to 2 years
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Time to Progression
Hide Description Time, in weeks, after treatment until disease progresses. Repeat radiologic studies to evaluate disease progression or response after 10 weeks of BAY 43 9006 therapy.
Time Frame Following 10 weeks of treatment or until disease progression
Outcome Measure Data Not Reported
Time Frame 1 year and 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sorafenib + Cytoreductive Nephrectomy
Hide Arm/Group Description All participants received Sorafenib 400 mg orally mouth twice a day for a total of 10 weeks over the course of the study and had surgical procedure Cytoreductive Nephrectomy before treatment with Sorafenib or in between courses of Sorafenib
All-Cause Mortality
Sorafenib + Cytoreductive Nephrectomy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sorafenib + Cytoreductive Nephrectomy
Affected / at Risk (%)
Total   1/10 (10.00%) 
Blood and lymphatic system disorders   
hyperuricemia  1  1/10 (10.00%) 
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%
Sorafenib + Cytoreductive Nephrectomy
Affected / at Risk (%)
Total   10/10 (100.00%) 
Blood and lymphatic system disorders   
hemoglobin  1  4/10 (40.00%) 
hemoglobinuria  1  1/10 (10.00%) 
hypertension  1  2/10 (20.00%) 
hyperuricemia  1  1/10 (10.00%) 
hypoalbuminemia  1  1/10 (10.00%) 
hypomagnesemia  1  4/10 (40.00%) 
hypophosphatemia  1  2/10 (20.00%) 
leukocytes  1  2/10 (20.00%) 
lymphopenia  1  1/10 (10.00%) 
neutrophils (ANC)  1 [1]  1/10 (10.00%) 
platelets  1  3/10 (30.00%) 
Hypokalemia  1  1/10 (10.00%) 
Eye disorders   
watery eye  1  1/10 (10.00%) 
Gastrointestinal disorders   
anorexia  1  1/10 (10.00%) 
diarrhea  1  4/10 (40.00%) 
dysphagia  1  1/10 (10.00%) 
nausea  1  3/10 (30.00%) 
vomiting  1  1/10 (10.00%) 
weight loss  1  1/10 (10.00%) 
General disorders   
alopecia  1  2/10 (20.00%) 
cough  1  1/10 (10.00%) 
dizziness  1  1/10 (10.00%) 
edema:head and neck  1  1/10 (10.00%) 
fatigue  1  10/10 (100.00%) 
hematoma  1  1/10 (10.00%) 
hyponatremia  1  1/10 (10.00%) 
mucositis  1  4/10 (40.00%) 
Infections and infestations   
infection (other),  1  1/10 (10.00%) 
Investigations   
pain (chest/thorax)  1  1/10 (10.00%) 
secondary malignancy  1  1/10 (10.00%) 
Metabolism and nutrition disorders   
Creatinine  1  1/10 (10.00%) 
Musculoskeletal and connective tissue disorders   
pain (joint)  1  1/10 (10.00%) 
Renal and urinary disorders   
proteinuria  1  1/10 (10.00%) 
Respiratory, thoracic and mediastinal disorders   
dyspnea  1  1/10 (10.00%) 
Skin and subcutaneous tissue disorders   
hand foot syndrome  1  1/10 (10.00%) 
rash/desquamation  1  4/10 (40.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
ANC = Absolute Neutrophil Count
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
Organization: UT MD Anderson Cancer Center
EMail: caperez@mdanderson.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00126659     History of Changes
Other Study ID Numbers: NCI-2012-02920
NCI-2012-02920 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000438709
2004-0516 ( Other Identifier: M D Anderson Cancer Center )
6630 ( Other Identifier: CTEP )
P30CA016672 ( U.S. NIH Grant/Contract )
N01CM62202 ( U.S. NIH Grant/Contract )
First Submitted: August 2, 2005
First Posted: August 4, 2005
Results First Submitted: September 28, 2012
Results First Posted: December 31, 2012
Last Update Posted: November 20, 2018