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Sunitinib Malate in Treating Patients With Previously Untreated Metastatic Kidney Cancer

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ClinicalTrials.gov Identifier: NCT01158222
Recruitment Status : Completed
First Posted : July 8, 2010
Results First Posted : August 16, 2018
Last Update Posted : September 14, 2018
Sponsor:
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
Conditions Clear Cell Renal Cell Carcinoma
Stage IV Renal Cell Cancer
Intervention Drug: sunitinib malate
Enrollment 37
Recruitment Details  
Pre-assignment Details 5 additional patients were consented but not enrolled in the study. No information was collected on them and they are not included in the patient flow. Demographics information was not collected on these patients.
Arm/Group Title Arm I
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Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.

sunitinib malate: Given orally

laboratory biomarker analysis: Correlative studies

reverse transcriptase-polymerase chain reaction: Correlative studies

polymorphism analysis: Correlative studies

Period Title: Overall Study
Started 37
Completed 20
Not Completed 17
Reason Not Completed
Not eligible for intermediate phase             17
Arm/Group Title Arm I
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Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.

sunitinib malate: Given orally

laboratory biomarker analysis: Correlative studies

reverse transcriptase-polymerase chain reaction: Correlative studies

polymorphism analysis: Correlative studies

Overall Number of Baseline Participants 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
40-49
3
   8.1%
50-59
9
  24.3%
60-69
18
  48.6%
70-79
6
  16.2%
80-89
1
   2.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Female
11
  29.7%
Male
26
  70.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
35
  94.6%
Unknown or Not Reported
2
   5.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 37 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
   2.7%
White
34
  91.9%
More than one race
0
   0.0%
Unknown or Not Reported
2
   5.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 37 participants
37
1.Primary Outcome
Title Feasibility as Assessed by Proportion of Patients Eligible for Intermittent Therapy Who Actually Receive it
Hide Description Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.
Time Frame after 6 months of treatment (4 cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.

sunitinib malate: Given orally

laboratory biomarker analysis: Correlative studies

reverse transcriptase-polymerase chain reaction: Correlative studies

polymorphism analysis: Correlative studies

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
20
 100.0%
2.Secondary Outcome
Title Change in Circulating Tumor Cells
Hide Description [Not Specified]
Time Frame Pre-treatment, day 1, and day 28 of every cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Did not complete this analysis. Data not collected.
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.

sunitinib malate: Given orally

laboratory biomarker analysis: Correlative studies

reverse transcriptase-polymerase chain reaction: Correlative studies

polymorphism analysis: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Relationship Between Hypertension and Germline VEGF Single Nucleotide Polymorphism (SNP) -634 Genotype
Hide Description [Not Specified]
Time Frame Day 28 of each cycle
Hide Outcome Measure Data
Hide Analysis Population Description
Did not complete this analysis. Data not collected.
Arm/Group Title Arm I
Hide Arm/Group Description:

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.

sunitinib malate: Given orally

laboratory biomarker analysis: Correlative studies

reverse transcriptase-polymerase chain reaction: Correlative studies

polymorphism analysis: Correlative studies

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I
Hide Arm/Group Description

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 42 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.

sunitinib malate: Given orally

laboratory biomarker analysis: Correlative studies

reverse transcriptase-polymerase chain reaction: Correlative studies

polymorphism analysis: Correlative studies

All-Cause Mortality
Arm I
Affected / at Risk (%)
Total   2/37 (5.41%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I
Affected / at Risk (%) # Events
Total   13/37 (35.14%)    
Cardiac disorders   
Atrial Fibrillation * 1  1/37 (2.70%)  1
Gastrointestinal disorders   
Abdominal Pain * 1  2/37 (5.41%)  2
Diarrhea * 1  1/37 (2.70%)  1
Gastrointestinal disorder - other * 1 [1]  1/37 (2.70%)  1
General disorders   
Chills * 1  1/37 (2.70%)  1
Edema Trunk * 1 [2]  1/37 (2.70%)  1
Fever * 1  1/37 (2.70%)  1
Infections and infestations   
Abdominal infection * 1  1/37 (2.70%)  1
Infection and infestation - other * 1 [3]  1/37 (2.70%)  1
Lung infection * 1  1/37 (2.70%)  1
Upper respiratory infection * 1  2/37 (5.41%)  2
Urinary tract infection * 1  1/37 (2.70%)  1
Investigations   
Weight Gain * 1  1/37 (2.70%)  1
Metabolism and nutrition disorders   
Hyperkalemia * 1  1/37 (2.70%)  1
Nervous system disorders   
Intracranial Hemorrhage * 1  1/37 (2.70%)  1
Syncope * 1  1/37 (2.70%)  2
Renal and urinary disorders   
Hematuria * 1  1/37 (2.70%)  1
Proteinuria * 1  1/37 (2.70%)  1
Renal and urinary disorders - other * 1 [4]  1/37 (2.70%)  1
Respiratory, thoracic and mediastinal disorders   
Hypoxia * 1  1/37 (2.70%)  2
Respiratory, thoracic and mediastinal disorders - other * 1 [5]  1/37 (2.70%)  1
Skin and subcutaneous tissue disorders   
Palmar-Plantar Erythrodysesthesia Syndrome * 1 [6]  1/37 (2.70%)  1
Vascular disorders   
Thromboembolic Event * 1 [7]  1/37 (2.70%)  1
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
[1]
GI bleeding
[2]
lower extremity edema
[3]
Infection
[4]
death from metastatic renal cancer
[5]
Pneumonia
[6]
Hand-Foot Syndrome
[7]
pulmonary embolism
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I
Affected / at Risk (%) # Events
Total   37/37 (100.00%)    
Blood and lymphatic system disorders   
Anemia * 1  26/37 (70.27%)  67
Blood and lymphatic system disorders - other * 1 [1]  2/37 (5.41%)  2
Endocrine disorders   
Hyperthyroidism * 1  3/37 (8.11%)  3
Hypothyroidism * 1  18/37 (48.65%)  24
Gastrointestinal disorders   
Abdominal distension * 1  2/37 (5.41%)  2
Abdominal Pain * 1  9/37 (24.32%)  12
Cheilitis * 1  4/37 (10.81%)  7
Constipation * 1  18/37 (48.65%)  32
Dental Caries * 1  2/37 (5.41%)  2
Diarrhea * 1  23/37 (62.16%)  88
Dry Mouth * 1  4/37 (10.81%)  5
Dyspepsia * 1  19/37 (51.35%)  35
Flatulence * 1  3/37 (8.11%)  4
Gastroesophageal Reflux Disease * 1  5/37 (13.51%)  6
Gastrointestinal Disorders - Other * 1 [2]  4/37 (10.81%)  9
Hemorrhoidal hemorrhage * 1  6/37 (16.22%)  6
Hemorrhoids * 1  7/37 (18.92%)  7
Lip Pain * 1  2/37 (5.41%)  2
Mucositis Oral * 1  31/37 (83.78%)  107
Nausea * 1  25/37 (67.57%)  75
Oral Hemorrhage * 1  3/37 (8.11%)  3
Oral Pain * 1  3/37 (8.11%)  5
Vomiting * 1  13/37 (35.14%)  25
General disorders   
Chills * 1  3/37 (8.11%)  5
Edema limbs * 1  11/37 (29.73%)  15
Fatigue * 1  35/37 (94.59%)  127
Fever * 1  4/37 (10.81%)  8
General Disorders - Other * 1 [3]  4/37 (10.81%)  4
Localized Edema * 1  2/37 (5.41%)  3
Pain * 1  15/37 (40.54%)  35
Infections and infestations   
Lung Infection * 1  2/37 (5.41%)  2
Mucosal Infection * 1  2/37 (5.41%)  3
Nail Infection * 1  2/37 (5.41%)  2
Pharyngitis * 1  3/37 (8.11%)  3
Rhinitis Infective * 1  2/37 (5.41%)  2
Skin Infection * 1  2/37 (5.41%)  9
Tooth Infection * 1  2/37 (5.41%)  4
Upper Respiratory Infection * 1  5/37 (13.51%)  6
Urinary Tract Infection * 1  4/37 (10.81%)  5
Injury, poisoning and procedural complications   
Bruising * 1  3/37 (8.11%)  6
Investigations   
Alanine Aminotransferase Increased * 1  10/37 (27.03%)  18
Alkaline Phosphatase Increased * 1  3/37 (8.11%)  5
Aspartate Aminotranferase Increased * 1  13/37 (35.14%)  34
Blood Bilirubin Increased * 1  4/37 (10.81%)  7
Creatinine Increased * 1  17/37 (45.95%)  39
Lymphocyte Count Decreased * 1  4/37 (10.81%)  6
Neutrophil Count Decreased * 1  18/37 (48.65%)  57
Platelet Count Decreased * 1  31/37 (83.78%)  115
Weight Gain * 1  3/37 (8.11%)  6
Weight Loss * 1  14/37 (37.84%)  16
White Blood Cell Decreased * 1  25/37 (67.57%)  73
Metabolism and nutrition disorders   
Anorexia * 1  19/37 (51.35%)  53
Dehydration * 1  5/37 (13.51%)  5
Hypercalcemia * 1  2/37 (5.41%)  3
Hyperclycemia * 1  8/37 (21.62%)  18
Hyperkalemia * 1  6/37 (16.22%)  11
Hyperuricemia * 1  3/37 (8.11%)  5
Hypoalbuminemia * 1  5/37 (13.51%)  12
Hypocalcemia * 1  2/37 (5.41%)  4
Hypokalemia * 1  2/37 (5.41%)  4
Hypomagnesemia * 1  4/37 (10.81%)  4
Hyponatremia * 1  10/37 (27.03%)  32
Hypophosphatemia * 1  5/37 (13.51%)  5
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  9/37 (24.32%)  121
Arthritis * 1  2/37 (5.41%)  3
Back Pain * 1  5/37 (13.51%)  5
Generalized Muscle Weakness * 1  4/37 (10.81%)  11
Muscle Weakness Lower Limb * 1  2/37 (5.41%)  3
Myalgia * 1  9/37 (24.32%)  20
Pain in Extremity * 1  11/37 (29.73%)  17
Bone Pain * 1  3/37 (8.11%)  8
Nervous system disorders   
Cognitive Disturbance * 1  4/37 (10.81%)  4
Dizziness * 1  6/37 (16.22%)  6
Dysgeusia * 1  26/37 (70.27%)  58
Headache * 1  10/37 (27.03%)  21
Syncope * 1  2/37 (5.41%)  2
Psychiatric disorders   
Anxiety * 1  4/37 (10.81%)  4
Depression * 1  5/37 (13.51%)  6
Insomnia * 1  3/37 (8.11%)  3
Renal and urinary disorders   
Hematuria * 1  2/37 (5.41%)  3
Respiratory, thoracic and mediastinal disorders   
Cough * 1  7/37 (18.92%)  9
Dyspnea * 1  3/37 (8.11%)  3
Epistaxis * 1  7/37 (18.92%)  12
Sore Throat * 1  2/37 (5.41%)  5
Voice Alteration * 1  3/37 (8.11%)  3
Skin and subcutaneous tissue disorders   
Alopecia * 1  4/37 (10.81%)  4
Dry Skin * 1  14/37 (37.84%)  22
Erythema Multiforme * 1  6/37 (16.22%)  11
Erythroderma * 1  2/37 (5.41%)  2
Pain of Skin * 1  4/37 (10.81%)  5
Palmar-plantar Erythrodysesthesia Syndrome * 1 [4]  20/37 (54.05%)  78
Pruritus * 1  8/37 (21.62%)  13
Purpura * 1  8/37 (21.62%)  18
Rash Acneiform * 1  10/37 (27.03%)  19
Scalp Pain * 1  2/37 (5.41%)  2
Skin and Subcutaneous Tissue Disorders - Other * 1 [5]  4/37 (10.81%)  12
Skin and Subcutaneous Tissue Disorders - Other * 1 [6]  6/37 (16.22%)  10
Vascular disorders   
Hot Flashes * 1  3/37 (8.11%)  3
Hypertension * 1  22/37 (59.46%)  45
1
Term from vocabulary, CTCAE (3.0)
*
Indicates events were collected by non-systematic assessment
[1]
erythrocytosis
[2]
Early Satiety
[3]
cold intolerance
[4]
hand and foot syndrome
[5]
desquamation
[6]
skin color change
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: Case Comprehensive Cancer Center
Phone: 216-444-9567
EMail: rinib2@ccf.org
Layout table for additonal information
Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01158222     History of Changes
Other Study ID Numbers: CASE8809
NCI-2010-01391 ( Other Identifier: NCI/CTRP )
First Submitted: July 6, 2010
First Posted: July 8, 2010
Results First Submitted: June 21, 2018
Results First Posted: August 16, 2018
Last Update Posted: September 14, 2018