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Sunitinib and Surgery in Treating Patients With Localized or Metastatic Kidney Cancer

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ClinicalTrials.gov Identifier: NCT00849186
Recruitment Status : Completed
First Posted : February 23, 2009
Results First Posted : February 6, 2015
Last Update Posted : February 6, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Kidney Cancer
Interventions Drug: sunitinib malate
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sunitinib Malate (Sunitinib)
Hide Arm/Group Description

sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery

neoadjuvant therapy: IV

therapeutic conventional surgery: Surgery

Period Title: Overall Study
Started 26
Completed 16
Not Completed 10
Reason Not Completed
Adverse Event             2
Withdrawal by Subject             1
not treated             6
Other             1
Arm/Group Title Sunitinib Malate (Sunitinib)
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sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery

neoadjuvant therapy: IV

therapeutic conventional surgery: Surgery

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
All treated and eligible patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
60.24  (9.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
9
  45.0%
Male
11
  55.0%
1.Primary Outcome
Title Safety of Sunitinib Malate (SM)
Hide Description Incident Rate: The proportion of the population who experience a grade 3 or higher endpoint-relevant toxic event within 3 months of the beginning of treatment.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Sunitinib Malate (Sunitinib)
Hide Arm/Group Description:

sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery

neoadjuvant therapy: IV

therapeutic conventional surgery: Surgery

Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
.350
(.1812 to .5671)
2.Primary Outcome
Title Safety of Surgery After 90 Days of Treatment With SM
Hide Description Incident Rate: Intraoperative Complication Rate
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Sunitinib Malate (Sunitinib)
Hide Arm/Group Description:

sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery

neoadjuvant therapy: IV

therapeutic conventional surgery: Surgery

Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
.150
(.0524 to .3604)
3.Secondary Outcome
Title Response Rate After 90 Days of Treatment With SM
Hide Description [Not Specified]
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title Sunitinib
Hide Arm/Group Description:

sunitinib malate: oral

neoadjuvant therapy: IV

therapeutic conventional surgery: Surgery

Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: proportion of participants
.20
(.0807 to .4160)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sunitinib
Hide Arm/Group Description

sunitinib malate: oral

neoadjuvant therapy: IV

therapeutic conventional surgery: Surgery

All-Cause Mortality
Sunitinib
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Sunitinib
Affected / at Risk (%) # Events
Total   0/20 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sunitinib
Affected / at Risk (%) # Events
Total   20/20 (100.00%)    
Blood and lymphatic system disorders   
Anaemia   1/20 (5.00%)  1
Leukopenia   7/20 (35.00%)  7
Neutropenia   4/20 (20.00%)  4
Thrombocytopenia   8/20 (40.00%)  8
White blood cell disorder   1/20 (5.00%)  1
Eye disorders   
Conjunctivitis   1/20 (5.00%)  1
Vision blurred   1/20 (5.00%)  1
Gastrointestinal disorders   
Abdominal distension   1/20 (5.00%)  1
Abdominal pain   4/20 (20.00%)  4
Abdominal pain upper   3/20 (15.00%)  3
Constipation   1/20 (5.00%)  1
Diarrhoea   6/20 (30.00%)  6
Dyspepsia   6/20 (30.00%)  6
Flatulence   4/20 (20.00%)  4
Gingival pain   1/20 (5.00%)  1
Nausea   8/20 (40.00%)  8
Oral discomfort   2/20 (10.00%)  2
Paraesthesia oral   1/20 (5.00%)  1
Stomatitis   3/20 (15.00%)  3
Toothache   1/20 (5.00%)  1
Vomiting   4/20 (20.00%)  5
General disorders   
Chest discomfort   1/20 (5.00%)  1
Chest pain   1/20 (5.00%)  1
Chills   1/20 (5.00%)  1
Fatigue   12/20 (60.00%)  13
Influenza like illness   1/20 (5.00%)  1
Mucosal inflammation   2/20 (10.00%)  2
Pyrexia   1/20 (5.00%)  1
Infections and infestations   
Urinary tract infection   2/20 (10.00%)  2
Injury, poisoning and procedural complications   
Depression postoperative   1/20 (5.00%)  1
Urinary retention postoperative   1/20 (5.00%)  1
Investigations   
Alanine aminotransferase increased   2/20 (10.00%)  2
Aspartate aminotransferase increased   8/20 (40.00%)  8
Blood alkaline phosphatase increased   1/20 (5.00%)  1
Blood amylase   1/20 (5.00%)  1
Blood amylase increased   2/20 (10.00%)  2
Blood creatinine   1/20 (5.00%)  1
Blood creatinine decreased   1/20 (5.00%)  1
Lipase   1/20 (5.00%)  1
Lipase increased   6/20 (30.00%)  6
Metabolism and nutrition disorders   
Hyperglycaemia   3/20 (15.00%)  3
Hyperkalaemia   2/20 (10.00%)  2
Hypocalcaemia   1/20 (5.00%)  1
Hyponatraemia   1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders   
Back pain   4/20 (20.00%)  4
Musculoskeletal chest pain   1/20 (5.00%)  1
Pain in extremity   1/20 (5.00%)  1
Nervous system disorders   
Dizziness   2/20 (10.00%)  3
Dysgeusia   2/20 (10.00%)  2
Headache   4/20 (20.00%)  4
Hypogeusia   1/20 (5.00%)  1
Paraesthesia   1/20 (5.00%)  1
Syncope   1/20 (5.00%)  1
Renal and urinary disorders   
Dysuria   1/20 (5.00%)  1
Urinary hesitation   1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea   1/20 (5.00%)  1
Pharyngolaryngeal pain   1/20 (5.00%)  1
Skin and subcutaneous tissue disorders   
Alopecia   1/20 (5.00%)  1
Dermatitis   1/20 (5.00%)  1
Dry skin   2/20 (10.00%)  2
Exfoliative rash   1/20 (5.00%)  1
Palmar-plantar erythrodysaesthesia syndrome   4/20 (20.00%)  4
Rash   1/20 (5.00%)  1
Surgical and medical procedures   
Arteriovenous fistula operation   1/20 (5.00%)  1
Vascular disorders   
Hypertension   5/20 (25.00%)  5
Indicates events were collected by systematic assessment
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: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
Layout table for additonal information
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00849186    
Other Study ID Numbers: CDR0000634770
P30CA016056 ( U.S. NIH Grant/Contract )
RPCI-I-95206
First Submitted: February 20, 2009
First Posted: February 23, 2009
Results First Submitted: January 22, 2015
Results First Posted: February 6, 2015
Last Update Posted: February 6, 2015