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Sunitinib in Treating Patients With Kidney Cancer That Cannot Be Removed by Surgery

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ClinicalTrials.gov Identifier: NCT00459979
Recruitment Status : Completed
First Posted : April 13, 2007
Results First Posted : January 7, 2014
Last Update Posted : March 7, 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
Interventions Drug: sunitinib malate
Procedure: conventional surgery
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sunitinib
Hide Arm/Group Description

sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily

conventional surgery : nephrectomy

Period Title: Overall Study
Started 30
Completed 28
Not Completed 2
Reason Not Completed
Withdrawal by Subject             1
Protocol Violation             1
Arm/Group Title Sunitinib
Hide Arm/Group Description

sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily

conventional surgery : nephrectomy

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Median age Number Analyzed 30 participants
61
(37 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
9
  30.0%
Male
21
  70.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
28
  93.3%
Unknown or Not Reported
2
   6.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   3.3%
White
27
  90.0%
More than one race
0
   0.0%
Unknown or Not Reported
2
   6.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Response to Sunitinib Therapy
Hide Description Defined as a reduction in tumor burden to such an extent that nephrectomy is permitted within 1 year of the start of therapy. No response to sunitinib therapy is defined as a nephrectomy not being permitted within 1 year of the start of therapy or removal from the study for any reason
Time Frame 1 year from start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol - analysis after at least one cycle of Sunitinib
Arm/Group Title Sunitinib
Hide Arm/Group Description:

sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily

conventional surgery : nephrectomy

Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: participants
13
2.Secondary Outcome
Title The Number of Patients With Any Type of Complication or Adverse Event
Hide Description The safety of sunitinib will be assessed by recording the number of patients with any type of complication or adverse event within 1 year of the start of therapy.
Time Frame 1 year from start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sunitinib
Hide Arm/Group Description:

sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily

conventional surgery : nephrectomy

Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: participants
28
3.Secondary Outcome
Title Progression Free Survival
Hide Description Progression free survival is defined as the amount of time (in months) between the start of treatment and documented RECIST defined progression. RECIST progression is defined as at least a 20% increase in the sum of diameters of target lesions, in addition to an absolute increase of at least 5mm.
Time Frame 1 year from start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sunitinib
Hide Arm/Group Description:

sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily

conventional surgery : nephrectomy

Overall Number of Participants Analyzed 28
Median (Full Range)
Unit of Measure: months
11.2
(1.7 to 36.5)
4.Secondary Outcome
Title Percent Decrease of Diameter of Primary Tumors
Hide Description Median percent decrease in size in all primary renal cell carcinoma tumors. Response was unconfirmed by RECIST criteria because patients went to surgery and did not undergo follow-up scans.
Time Frame 1 year from start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol - analysis after at least one cycle of Sunitinib
Arm/Group Title Sunitinib
Hide Arm/Group Description:

sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily

conventional surgery : nephrectomy

Overall Number of Participants Analyzed 28
Overall Number of Units Analyzed
Type of Units Analyzed: Tumors
35
Median (Full Range)
Unit of Measure: percentage of tumors diameter decrease
22
(-13 to 100)
5.Secondary Outcome
Title Number of Tumors Which Decreased in Size
Hide Description Number of tumors with at least some reduction in longest primary tumor diameter. Response was unconfirmed by RECIST criteria because patients went to surgery and did not undergo follow-up scans.
Time Frame 1 year from start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol - after at lease one cycle of Sunitinib
Arm/Group Title Sunitinib
Hide Arm/Group Description:

sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily

conventional surgery : nephrectomy

Overall Number of Participants Analyzed 28
Overall Number of Units Analyzed
Type of Units Analyzed: Tumors
35
Measure Type: Number
Unit of Measure: tumors
28
6.Secondary Outcome
Title Number of Tumors With 30% Reduction in Size
Hide Description Number of tumors with at least 30% reduction in longest primary tumor diameter. Response was unconfirmed by RECIST criteria because patients went to surgery and did not undergo follow-up scans.
Time Frame 1 year from start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
per protocol- after at least one cycle of Sunitinib
Arm/Group Title Sunitinib
Hide Arm/Group Description:

sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily

conventional surgery : nephrectomy

Overall Number of Participants Analyzed 28
Overall Number of Units Analyzed
Type of Units Analyzed: Tumors
35
Measure Type: Number
Unit of Measure: tumors
13
7.Secondary Outcome
Title Median Size Reduction Among Tumors With Some Shrinkage
Hide Description The median size reduction in the largest diameter of the primary RCC tumor among the tumors with at least some shrinkage in diameter
Time Frame 1 year from start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sunitinib
Hide Arm/Group Description:

sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily

conventional surgery : nephrectomy

Overall Number of Participants Analyzed 28
Overall Number of Units Analyzed
Type of Units Analyzed: Tumors with size reduction
28
Median (Full Range)
Unit of Measure: cm
1.6
(0.4 to 5.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sunitinib
Hide Arm/Group Description

sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily

conventional surgery : nephrectomy

All-Cause Mortality
Sunitinib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sunitinib
Affected / at Risk (%)
Total   16/28 (57.14%) 
Blood and lymphatic system disorders   
Hemoglobin * 1  4/28 (14.29%) 
Platelets * 1  1/28 (3.57%) 
Supraventricular and nodal arrhythmia - Atrial fibrillation * 1  2/28 (7.14%) 
Cardiac disorders   
Cardiac ischemia/infarction * 1  1/28 (3.57%) 
Gastrointestinal disorders   
Perforated Bowel * 1  1/28 (3.57%) 
Obstruction, GI - Small bowel NOS * 1  1/28 (3.57%) 
Pain - Abdomen NOS * 1  3/28 (10.71%) 
General disorders   
Fatigue (asthenia, lethargy, malaise) * 1  1/28 (3.57%) 
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) * 1  1/28 (3.57%) 
Death not associated with CTCAE term - Disease progression NOS * 1  2/28 (7.14%) 
"Pain - NOS * 1  1/28 (3.57%) 
Infections and infestations   
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS * 1  1/28 (3.57%) 
Metabolism and nutrition disorders   
Dehydration * 1  1/28 (3.57%) 
Sodium, serum-low (hyponatremia) * 1  1/28 (3.57%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Pain - Tumor pain * 1  1/28 (3.57%) 
Renal and urinary disorders   
Obstruction, GU - Bladder * 1  1/28 (3.57%) 
Reproductive system and breast disorders   
Hemorrhage, GU - Urinary NOS * 1  3/28 (10.71%) 
Respiratory, thoracic and mediastinal disorders   
Hemorrhage, pulmonary/upper respiratory - Respiratory tract NOS * 1  1/28 (3.57%) 
Dyspnea (shortness of breath) * 1  3/28 (10.71%) 
Pleural effusion (non-malignant) * 1  2/28 (7.14%) 
Vascular disorders   
Hypotension * 1  1/28 (3.57%) 
Thrombosis/thrombus/embolism * 1  6/28 (21.43%) 
*
Indicates events were collected by non-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%
Sunitinib
Affected / at Risk (%)
Total   28/28 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin * 1  17/28 (60.71%) 
Edema: head and neck * 1  4/28 (14.29%) 
Edema: limb * 1  2/28 (7.14%) 
Endocrine disorders   
Thyroid function, low (hypothyroidism) * 1  13/28 (46.43%) 
Gastrointestinal disorders   
Anorexia * 1  16/28 (57.14%) 
Constipation * 1  18/28 (64.29%) 
Dehydration * 1  5/28 (17.86%) 
Diarrhea * 1  23/28 (82.14%) 
Distension/bloating, abdominal * 1  2/28 (7.14%) 
Dry mouth/salivary gland (xerostomia) * 1  3/28 (10.71%) 
Gastrointestinal - Other (Specify, __) * 1  3/28 (10.71%) 
Heartburn/dyspepsia * 1  12/28 (42.86%) 
Hemorrhoids * 1  6/28 (21.43%) 
Mucositis/stomatitis (clinical exam) - Oral cavity * 1  7/28 (25.00%) 
Mucositis/stomatitis (functional/symptomatic) - Oral cavity * 1  20/28 (71.43%) 
Nausea * 1  17/28 (60.71%) 
Taste alteration (dysgeusia) * 1  19/28 (67.86%) 
Vomiting * 1  12/28 (42.86%) 
Hemorrhage, GI - Oral cavity * 1  2/28 (7.14%) 
Hemorrhage, GI - Rectum * 1  6/28 (21.43%) 
Pain - Abdomen NOS * 1  9/28 (32.14%) 
Pain - Dental/teeth/peridontal * 1  2/28 (7.14%) 
Pain - Oral cavity * 1  3/28 (10.71%) 
Pain - Rectum * 1  6/28 (21.43%) 
General disorders   
Constitutional Symptoms - Other (Specify, __) * 1  5/28 (17.86%) 
Fatigue (asthenia, lethargy, malaise) * 1  24/28 (85.71%) 
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L) * 1  2/28 (7.14%) 
Insomnia * 1  3/28 (10.71%) 
Weight loss * 1  4/28 (14.29%) 
Pain - Other (Specify, __) * 1  2/28 (7.14%) 
Infections and infestations   
Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS * 1  2/28 (7.14%) 
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS * 1  7/28 (25.00%) 
Infection with unknown ANC - Dental-tooth * 1  2/28 (7.14%) 
Infection with unknown ANC - Pharynx * 1  4/28 (14.29%) 
Investigations   
Leukocytes (total WBC) * 1  12/28 (42.86%) 
Lymphopenia * 1  4/28 (14.29%) 
Neutrophils/granulocytes (ANC/AGC) * 1  12/28 (42.86%) 
Platelets * 1  22/28 (78.57%) 
Alkaline phosphatase * 1  2/28 (7.14%) 
ALT, SGPT (serum glutamic pyruvic transaminase) * 1  9/28 (32.14%) 
AST, SGOT(serum glutamic oxaloacetic transaminase) * 1  12/28 (42.86%) 
Bilirubin (hyperbilirubinemia) * 1  3/28 (10.71%) 
Creatinine * 1  11/28 (39.29%) 
Metabolism and nutrition disorders   
Albumin, serum-low (hypoalbuminemia) * 1  3/28 (10.71%) 
Calcium, serum-low (hypocalcemia) * 1  2/28 (7.14%) 
Glucose, serum-high (hyperglycemia) * 1  4/28 (14.29%) 
Glucose, serum-low (hypoglycemia) * 1  2/28 (7.14%) 
Phosphate, serum-low (hypophosphatemia) * 1  4/28 (14.29%) 
Potassium, serum-high (hyperkalemia) * 1  3/28 (10.71%) 
Potassium, serum-low (hypokalemia) * 1  3/28 (10.71%) 
Sodium, serum-low (hyponatremia) * 1  6/28 (21.43%) 
Musculoskeletal and connective tissue disorders   
Uric acid, serum-high (hyperuricemia) * 1  3/28 (10.71%) 
Pain - Back * 1  4/28 (14.29%) 
Pain - Chest wall * 1  2/28 (7.14%) 
Pain - Extremity-limb * 1  12/28 (42.86%) 
Pain - Joint * 1  5/28 (17.86%) 
Pain - Muscle * 1  4/28 (14.29%) 
Nervous system disorders   
Dizziness * 1  10/28 (35.71%) 
Neuropathy: sensory * 1  3/28 (10.71%) 
Syncope (fainting) * 1  2/28 (7.14%) 
Pain - Head/headache * 1  8/28 (28.57%) 
Renal and urinary disorders   
Hemorrhage, GU - Urinary NOS * 1  5/28 (17.86%) 
Respiratory, thoracic and mediastinal disorders   
Hemorrhage, pulmonary/upper respiratory - Nose * 1  8/28 (28.57%) 
Hemorrhage, pulmonary/upper respiratory - Respiratory tract NOS * 1  3/28 (10.71%) 
Cough * 1  3/28 (10.71%) 
Dyspnea (shortness of breath) * 1  6/28 (21.43%) 
Hiccoughs (hiccups, singultus) * 1  2/28 (7.14%) 
Nasal cavity/paranasal sinus reactions * 1  3/28 (10.71%) 
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) * 1  2/28 (7.14%) 
Skin and subcutaneous tissue disorders   
Cheilitis * 1  4/28 (14.29%) 
Dermatology/Skin - Other * 1  11/28 (39.29%) 
Dry skin * 1  9/28 (32.14%) 
Hypopigmentation * 1  6/28 (21.43%) 
Pruritus/itching * 1  3/28 (10.71%) 
Rash/desquamation * 1  13/28 (46.43%) 
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) * 1  8/28 (28.57%) 
Rash: hand-foot skin reaction * 1  19/28 (67.86%) 
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa) * 1  3/28 (10.71%) 
Vascular disorders   
Hypertension * 1  14/28 (50.00%) 
Hypotension * 1  4/28 (14.29%) 
Hematoma * 1  2/28 (7.14%) 
Hemorrhage/Bleeding - Other * 1  2/28 (7.14%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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: CCCC
Phone: 216-444-9567
EMail: rinib2@ccf.org
Layout table for additonal information
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00459979     History of Changes
Other Study ID Numbers: CASE17806
P30CA043703 ( U.S. NIH Grant/Contract )
CASE-17806 ( Other Identifier: Case Comprehensive Cancer Center )
CASE-17806-CC209 ( Other Identifier: Cancer Center IRB )
First Submitted: April 11, 2007
First Posted: April 13, 2007
Results First Submitted: November 19, 2013
Results First Posted: January 7, 2014
Last Update Posted: March 7, 2014