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Sorafenib in Treating Patients With Metastatic or Unresectable Kidney Cancer

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ClinicalTrials.gov Identifier: NCT00496756
Recruitment Status : Terminated (Low accrual rate.)
First Posted : July 4, 2007
Results First Posted : February 15, 2019
Last Update Posted : March 12, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Bayer
Information provided by (Responsible Party):
University of Nebraska

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Kidney Cancer
Intervention Drug: Sorafenib
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sorafenib
Hide Arm/Group Description

The initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily. Intrapatient dose escalation will occur as defined in the table below, providing no dose limiting toxicity (Grade 3 or 4) is observed. If grade 3 or 4 toxicity is observed, delay and dose modification will occur as defined in protocol. Once dose level 3 is reached, the patient will remain at that dose as defined in the protocol.

Dose Level 1 Day 1-28 400 mg b.i.d. Dose Level 2 Day 29-56 600 mg b.i.d. Dose Level 3 Day 57- 800 mg b.i.d.

A treatment cycle will be 4 weeks.

Two 4-week cycles will be administered. At the completion of two cycles (week 8), restaging will occur. Patients will continue on therapy per study protocol.

Period Title: Overall Study
Started 14
Completed 11
Not Completed 3
Arm/Group Title Sorafenib
Hide Arm/Group Description

sorafenib tosylate: initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily.Intrapatient dose escalation will occur providing no dose limiting toxicity (Grade 3 or 4) is observed. Dose level 2 600mg. Dose level 2 800mg

flow cytometry: 15 ml of blood drawn for flow cytometry of T4/T8, NK, CD25+, and Fox p3 testing obtained at baseline and on days 28, 56, 84, and 112

laboratory biomarker analysis: 15 ml of plasma and urine for storage and future determination of VEGF concentration will be obtained at baseline.10 ml of plasma and urine for storage and future determination of VEGF concentration will be obtained on days 28, 56, 84 and 112

Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Patients greater than or equal to 19 years of age Number Analyzed 14 participants
14
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
3
  21.4%
Male
11
  78.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
14
 100.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
1.Primary Outcome
Title Toxicity of Intrapatient Dose Escalation of Sorafenib Tosylate
Hide Description To evaluate the toxicity of dose escalating sorafenib, an estimation of the percentage of patients who are unable to tolerate those escalated doses will be made. Patients will be dose escalated every 4 weeks until a maximum dose of 800 mg BID is reached.
Time Frame Study completion
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluation of this data is not possible as the investigator performing the analysis has left the study center prior to completing the analysis and data was not provided.
Arm/Group Title Sorafenib
Hide Arm/Group Description:

The initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily. Intrapatient dose escalation will occur as defined in the table below, providing no dose limiting toxicity (Grade 3 or 4) is observed. If grade 3 or 4 toxicity is observed, delay and dose modification will occur as defined in protocol. Once dose level 3 is reached, the patient will remain at that dose as defined in the protocol.

Dose Level 1 Day 1-28 400 mg b.i.d. Dose Level 2 Day 29-56 600 mg b.i.d. Dose Level 3 Day 57- 800 mg b.i.d.

A treatment cycle will be 4 weeks.

Two 4-week cycles will be administered. At the completion of two cycles (week 8), restaging will occur. Patients will continue on therapy per study protocol.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Response Rate
Hide Description The proportion of subjects with an objective response of complete or partial based on the RECIST Criteria
Time Frame from the start of the treatment until disease progression/recurrence
Hide Outcome Measure Data
Hide Analysis Population Description
Evaluation of this data is not possible as the investigator performing the analysis has left the study center prior to completing the analysis and data was not provided.
Arm/Group Title Sorafenib
Hide Arm/Group Description:

The initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily. Intrapatient dose escalation will occur as defined in the table below, providing no dose limiting toxicity (Grade 3 or 4) is observed. If grade 3 or 4 toxicity is observed, delay and dose modification will occur as defined in protocol. Once dose level 3 is reached, the patient will remain at that dose as defined in the protocol.

Dose Level 1 Day 1-28 400 mg b.i.d. Dose Level 2 Day 29-56 600 mg b.i.d. Dose Level 3 Day 57- 800 mg b.i.d.

A treatment cycle will be 4 weeks.

Two 4-week cycles will be administered. At the completion of two cycles (week 8), restaging will occur. Patients will continue on therapy per study protocol.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events and serious adverse events will be collected and reported on the forms beginning with the first dose of investigational product and continuing through the end of the study. (approximately 4 months)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sorafenib
Hide Arm/Group Description

The initial dose of Sorafenib will be administered orally with a dose of 400 mg twice a day, daily. Intrapatient dose escalation will occur as defined in the table below, providing no dose limiting toxicity (Grade 3 or 4) is observed. If grade 3 or 4 toxicity is observed, delay and dose modification will occur as defined in protocol. Once dose level 3 is reached, the patient will remain at that dose as defined in the protocol.

Dose Level 1 Day 1-28 400 mg b.i.d. Dose Level 2 Day 29-56 600 mg b.i.d. Dose Level 3 Day 57- 800 mg b.i.d.

A treatment cycle will be 4 weeks.

Two 4-week cycles will be administered. At the completion of two cycles (week 8), restaging will occur. Patients will continue on therapy per study protocol.

All-Cause Mortality
Sorafenib
Affected / at Risk (%)
Total   6/14 (42.86%)    
Show Serious Adverse Events Hide Serious Adverse Events
Sorafenib
Affected / at Risk (%) # Events
Total   2/14 (14.29%)    
General disorders   
Other, weakness  1  1/14 (7.14%)  1
Other, extremities tingling, numbness  1  1/14 (7.14%)  1
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1  1/14 (7.14%)  1
Other, shortness of breath  1  1/14 (7.14%)  1
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
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 (%) # Events
Total   11/14 (78.57%)    
Blood and lymphatic system disorders   
Anemia  1  3/14 (21.43%)  3
Other, Thrombocytopenia  1  1/14 (7.14%)  1
Cardiac disorders   
Other, elevated cardiac enzymes  1  1/14 (7.14%)  1
Eye disorders   
Retinal detachment  1  1/14 (7.14%)  1
Gastrointestinal disorders   
Diarrhea  1  8/14 (57.14%)  10
Other, upset stomach  1  1/14 (7.14%)  2
Nausea  1  4/14 (28.57%)  4
Vomiting  1  3/14 (21.43%)  3
Gastroparesis  1  2/14 (14.29%)  2
Constipation  1  1/14 (7.14%)  1
Other, stomach cramps  1  1/14 (7.14%)  1
Other, blood in stool  1  1/14 (7.14%)  1
Other, hematemesis  1  1/14 (7.14%)  1
Other, soreness mouth and throat  1  1/14 (7.14%)  1
Ileus  1  1/14 (7.14%)  1
Other, Hematochezia  1  1/14 (7.14%)  1
General disorders   
Other, pain  1  5/14 (35.71%)  8
Fatigue  1  5/14 (35.71%)  9
Other, mouth sensitivity  1  1/14 (7.14%)  1
Other, cramping  1  2/14 (14.29%)  3
Other, Weakness  1  1/14 (7.14%)  1
Infections and infestations   
Other, Bleeding gums  1  1/14 (7.14%)  1
Other, Leukoplakia  1 [1]  1/14 (7.14%)  1
Investigations   
Ejection fraction decreased  1  1/14 (7.14%)  1
Weight loss  1  2/14 (14.29%)  2
Other, increased alkaline phosphatase  1  1/14 (7.14%)  1
Other, weak urine stream  1  1/14 (7.14%)  1
Other, pale face  1  1/14 (7.14%)  1
Aspartate aminotransferase increased  1  1/14 (7.14%)  1
Other, decreased ionized calcium level  1  1/14 (7.14%)  1
Other, decreased magnesium level  1  1/14 (7.14%)  1
Metabolism and nutrition disorders   
Hyperglycemia  1  2/14 (14.29%)  2
Hyperkalemia  1  1/14 (7.14%)  1
Hyponatremia  1  1/14 (7.14%)  1
Hypocalcemia  1  1/14 (7.14%)  1
Anorexia  1  1/14 (7.14%)  1
Hypokalemia  1  1/14 (7.14%)  1
Musculoskeletal and connective tissue disorders   
Other, Soreness  1 [2]  1/14 (7.14%)  1
Nervous system disorders   
Headache  1  2/14 (14.29%)  3
Other, Neuropathy  1  1/14 (7.14%)  1
Psychiatric disorders   
Insomnia  1  1/14 (7.14%)  1
Renal and urinary disorders   
Proteinuria  1  3/14 (21.43%)  3
Other, renal insufficiency  1  1/14 (7.14%)  1
Hematuria (trace)  1  1/14 (7.14%)  1
Respiratory, thoracic and mediastinal disorders   
Pleural effusion  1  1/14 (7.14%)  1
Productive cough  1  1/14 (7.14%)  1
Pleuritic pain  1  1/14 (7.14%)  1
Dyspnea  1  1/14 (7.14%)  1
Other, pneumonitis  1  1/14 (7.14%)  1
Epistaxis  1  1/14 (7.14%)  1
Skin and subcutaneous tissue disorders   
Other- rash  1 [3]  4/14 (28.57%)  7
Other, hand foot syndrome  1  7/14 (50.00%)  7
Alopecia  1  4/14 (28.57%)  4
Dry skin  1  1/14 (7.14%)  1
Other, Blisters  1 [4]  1/14 (7.14%)  2
Other, tingling hands  1  1/14 (7.14%)  1
Other, lesions  1  1/14 (7.14%)  1
Other, cracking, erythema fingertips  1  1/14 (7.14%)  1
Other, Tenderness/burning scalp  1  1/14 (7.14%)  1
Other, Stomatitis  1  1/14 (7.14%)  1
Vascular disorders   
Hypertension  1  6/14 (42.86%)  6
Other, DVT  1 [5]  1/14 (7.14%)  1
Other, pulmonary embolus  1  1/14 (7.14%)  1
Other, swelling  1 [6]  2/14 (14.29%)  2
1
Term from vocabulary, CTCAE (3.0)
Indicates events were collected by systematic assessment
[1]
oral
[2]
extremities
[3]
face
[4]
hands, foot
[5]
left leg
[6]
hands and feet, left leg
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: Ralph Hauke, MD
Organization: University of Nebraska Medical Center
Phone: 402-354-8124
EMail: rhauke@nebraskacancer.com
Layout table for additonal information
Responsible Party: University of Nebraska
ClinicalTrials.gov Identifier: NCT00496756     History of Changes
Other Study ID Numbers: 081-06
P30CA036727 ( U.S. NIH Grant/Contract )
UNMC-08106
First Submitted: July 3, 2007
First Posted: July 4, 2007
Results First Submitted: January 23, 2019
Results First Posted: February 15, 2019
Last Update Posted: March 12, 2019