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Sunitinib Scheduling in Metastatic Renal Cell Carcinoma (mRCC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02060370
Recruitment Status : Completed
First Posted : February 12, 2014
Results First Posted : February 27, 2020
Last Update Posted : February 27, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Genitourinary Cancer
Kidney Cancer
Interventions Drug: Sunitinib
Behavioral: Questionnaire
Enrollment 60
Recruitment Details Sixty participants enrolled between August 2014 and March 2016. Participants recruited from The University of Texas MD Anderson Cancer Center, Cleveland Clinic Foundation, Fox Chase Cancer Center, and University of North Carolina Lineberger Cancer Center). All participants had confirmed treatment naive metastatic clear cell renal cell carcinoma.
Pre-assignment Details One participant did not take the study medication due to declining mental health status before the first dose was initiated. Consequently, only 59 patients were included in the final analysis.
Arm/Group Title Alternating Sunitinib
Hide Arm/Group Description Starting dose of 50 mg by mouth daily for 2 weeks followed by 1 week of no drug. 1 cycle equaled six weeks.
Period Title: Overall Study
Started 60
Completed 59
Not Completed 1
Reason Not Completed
Physician Decision             1
Arm/Group Title Sunitinib
Hide Arm/Group Description

Sunitinib starting dose 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.

Sunitinib: Starting dose: 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.

Questionnaire: Questionnaire completion on Day 1 of Cycle 1, and on Day 35 of Cycles 2, 4, and 6.

Overall Number of Baseline Participants 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 60 participants
65
(45 to 92)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Female
23
  38.3%
Male
37
  61.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Hispanic or Latino
7
  11.7%
Not Hispanic or Latino
0
   0.0%
Unknown or Not Reported
53
  88.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
American Indian or Alaska Native
1
   1.7%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
50
  83.3%
More than one race
0
   0.0%
Unknown or Not Reported
9
  15.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants
60
Memorial Sloan Kettering Cancer Center (MSKCC) Risk Factor   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Good
13
  21.7%
Intermediate
40
  66.7%
Poor
6
  10.0%
Unknown
1
   1.7%
[1]
Measure Description: Method used to predict survivability of participants at outset of treatment
Number of Metastatic Sites   [1] 
Median (Full Range)
Unit of measure:  Number of metastatic sites
Number Analyzed 60 participants
2
(1 to 4)
[1]
Measure Description: Describes the extent of the participants' advance disease
Metastatic Sites  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants
Lung
39
  65.0%
Lymph node
10
  16.7%
Liver
8
  13.3%
Bone
3
   5.0%
Other
29
  48.3%
1.Primary Outcome
Title Rate of Toxicity
Hide Description Determine the number of participants who experience a specific, treatment-related adverse events at a grade three, four or five: fatigue, hand-foot syndrome, and/or diarrhea. Adverse events as defined by the Common Terminology Criteria for Adverse Events (CTCAE) version 4
Time Frame Participants were monitored for toxicities for 30 days after treatment was discontinued; total treatment duration approximately 34 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alternating Sunitinib
Hide Arm/Group Description:
Starting dose of 50 mg by mouth daily for 2 weeks followed by 1 week of no drug. 1 cycle equaled six weeks.
Overall Number of Participants Analyzed 59
Measure Type: Count of Participants
Unit of Measure: Participants
Grade>=3, of all 3 adverse events
15
  25.4%
Fatigue, Grade >=3
8
  13.6%
Diarrhea, Grade >=3
5
   8.5%
Hand-foot syndrome, Grade >=3
3
   5.1%
2.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame 17 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alternating Sunitinib
Hide Arm/Group Description:
Starting dose of 50 mg by mouth daily for 2 weeks followed by 1 week of no drug. 1 cycle equaled six weeks.
Overall Number of Participants Analyzed 59
Median (95% Confidence Interval)
Unit of Measure: months
13.7
(10.9 to 16.3)
3.Secondary Outcome
Title The Number and Percentage of Participants Who Experienced a Grade 3, 4, or 5 Adverse Event
Hide Description Adverse events as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 4
Time Frame Participants were monitored for toxicities for 30 days after treatment was discontinued or until death, whichever occurred first.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Alternating Sunitinib
Hide Arm/Group Description:
Starting dose of 50 mg by mouth daily for 2 weeks followed by 1 week of no drug. 1 cycle equaled six weeks.
Overall Number of Participants Analyzed 59
Measure Type: Count of Participants
Unit of Measure: Participants
Any grade ≥3 event
35
  59.3%
Alkaline phosphatase increased
1
   1.7%
Anemia
6
  10.2%
Dehydration
1
   1.7%
Diarrhea
5
   8.5%
Fatigue
8
  13.6%
Pancreatic insufficiency
1
   1.7%
Headache
1
   1.7%
Hypertension
16
  27.1%
Hyponatremia
2
   3.4%
Hypophosphatemia
1
   1.7%
Lymphocyte count decreased
1
   1.7%
Mucositis oral
5
   8.5%
Gout
1
   1.7%
Neutrophil count decreased
8
  13.6%
Hand-foot syndrome
3
   5.1%
Platelet count decreased
2
   3.4%
Thromboembolic event
3
   5.1%
Urticaria
1
   1.7%
Vascular access complication
1
   1.7%
Vomiting
1
   1.7%
White blood cell decreased
4
   6.8%
4.Secondary Outcome
Title Dose Reductions and Treatment Discontinuations Due to Unacceptable Toxicities
Hide Description Reported as the number and percentage of participants who underwent one or more dose reductions, as well as, the number and percentage of participants whose treatment ended.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Out of the 59 participants only 29 encountered a dose reduction. The number of dose reductions a participant experienced was also reported with the percentage being based on the 29 participants who had a reduction.
Arm/Group Title Alternating Sunitinib
Hide Arm/Group Description:
Starting dose of 50 mg by mouth daily for 2 weeks followed by 1 week of no drug. 1 cycle equaled six weeks.
Overall Number of Participants Analyzed 59
Measure Type: Count of Participants
Unit of Measure: Participants
1 Dose Reduction
7
  11.9%
2 Dose Reductions
14
  23.7%
3 Dose Reductions
3
   5.1%
4 Dose Reductions
5
   8.5%
5.Secondary Outcome
Title Changes in Participant Reported Outcomes in the Functional Assessment of Cancer Therapy-General (FACT-G)
Hide Description Participants completed FACT-G suveys evaluating quality of life at weeks 0, 12, 24, and 36. The score range is from 0 to 180 with higher scores reflecting a better quality of life. The results were reported for each time point for all participants and then broken into two groups: participants with a grade 3 toxicity and participants without a grade 3 toxicity. The total number of surveys changes as the weeks progress.
Time Frame 36 weeks from the start of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
The number of surveys collected at week 0, 12,24, and 36 are 54, 49, 44, and 35 surveys.The number of surveys with a grade 3 toxicity collected at week 0, 12, 24, and 36 are 14, 11, 12, and 10 surveys. The number of surveys without a grade 3 toxicity collected at week 0, 12, 24, and 36 are 40, 38, 32, and 25 surveys.
Arm/Group Title Alternating Sunitinib
Hide Arm/Group Description:
Starting dose of 50 mg by mouth daily for 2 weeks followed by 1 week of no drug. 1 cycle equaled six weeks.
Overall Number of Participants Analyzed 54
Median (Full Range)
Unit of Measure: Score on a scale
All Participants- week 0
87.8
(57.7 to 108)
All Participants- week 12
88
(46 to 106)
All Participants- week 24
86
(44 to 108)
All Participants- week 36
89
(61 to 106)
Grade 3 tox - week 0
86.8
(56 to 108)
Grade 3 tox - week 12
79.5
(46 to 100)
Grade 3 tox - week 24
79
(44 to 106)
Grade 3 tox - week 36
83
(63 to 106)
No grade 3 tox - week 0
88.8
(52.7 to 105)
No grade 3 tox - week 12
89.8
(46.8 to 106)
No grade 3 tox - week 24
91.8
(55.2 to 108)
No grade 3 tox - week 36
93.8
(61 to 104)
6.Secondary Outcome
Title Changes in Circulating DNA Levels With Antiangiogenic Treatment
Hide Description [Not Specified]
Time Frame Not applicable due data not generated due to timing and budgetary issues
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected due to timing and budgetary issues.
Arm/Group Title Alternating Sunitinib
Hide Arm/Group Description:
Starting dose of 50 mg by mouth daily for 2 weeks followed by 1 week of no drug. 1 cycle equaled six weeks.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Toxicities were monitored from the first dose until 30 days after the last dose of study drug was given, monitoring was approximately 36 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sunitinib
Hide Arm/Group Description

Sunitinib starting dose 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.

Sunitinib: Starting dose: 50 mg by mouth daily given for 2 weeks "on" followed by 1 week "off". 1 cycle is 6 weeks.

Questionnaire: Questionnaire completion on Day 1 of Cycle 1, and on Day 35 of Cycles 2, 4, and 6.

All-Cause Mortality
Sunitinib
Affected / at Risk (%)
Total   2/59 (3.39%) 
Hide Serious Adverse Events
Sunitinib
Affected / at Risk (%)
Total   35/59 (59.32%) 
Blood and lymphatic system disorders   
Anemia  1  6/59 (10.17%) 
Lymphocyte count decreased  1  1/59 (1.69%) 
Neutrophil count decreased  1  8/59 (13.56%) 
Platelet count decreased  1  2/59 (3.39%) 
White blood cell decreased  1  4/59 (6.78%) 
Endocrine disorders   
Pancreatic insufficiency  1  1/59 (1.69%) 
Gastrointestinal disorders   
Diarrhea  1  5/59 (8.47%) 
Lymphocyte count decreased  1  1/59 (1.69%) 
Mucositis oral  1  5/59 (8.47%) 
Vomiting  1  1/59 (1.69%) 
General disorders   
Fatigue  1  8/59 (13.56%) 
Investigations   
Alkaline phosphatase increased  1  1/59 (1.69%) 
Metabolism and nutrition disorders   
Dehydration  1  1/59 (1.69%) 
Hyponatremia  1  2/59 (3.39%) 
Hypophosphatemia  1  1/59 (1.69%) 
Gout  1  1/59 (1.69%) 
Nervous system disorders   
Headache  1  1/59 (1.69%) 
Skin and subcutaneous tissue disorders   
Hand-foot syndrome  1  3/59 (5.08%) 
Urticaria  1  1/59 (1.69%) 
Vascular disorders   
Hypertension  1  16/59 (27.12%) 
Thromboembolic event  1  3/59 (5.08%) 
Vascular access complication  1  1/59 (1.69%) 
1
Term from vocabulary, CTCAE version 4
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sunitinib
Affected / at Risk (%)
Total   59/59 (100.00%) 
Blood and lymphatic system disorders   
Anemia  1  32/59 (54.24%) 
Lymphocyte count decreased  1  7/59 (11.86%) 
Neutrophil count decreased  1  23/59 (38.98%) 
Thrombotic thrombocytopenic purpura  1  3/59 (5.08%) 
White blood cell decreased  1  34/59 (57.63%) 
Endocrine disorders   
TSH increased  1  5/59 (8.47%) 
Hypothyroidism  1  15/59 (25.42%) 
Eye disorders   
Watering eyes  1  10/59 (16.95%) 
Gastrointestinal disorders   
Abdominal pain  1  3/59 (5.08%) 
Anal mucositis  1  4/59 (6.78%) 
Anorexia  1  12/59 (20.34%) 
Bloating  1  3/59 (5.08%) 
Constipation  1  6/59 (10.17%) 
Diarrhea  1  45/59 (76.27%) 
Dry mouth  1  4/59 (6.78%) 
Dyspepsia  1  13/59 (22.03%) 
Gastroesophageal reflux disease  1  7/59 (11.86%) 
Mucositis oral  1  32/59 (54.24%) 
Nausea  1  26/59 (44.07%) 
Oral dysesthesia  1  8/59 (13.56%) 
Vomiting  1  14/59 (23.73%) 
General disorders   
Edema  1  9/59 (15.25%) 
Fatigue  1  49/59 (83.05%) 
Non-cardiac chest pain  1  4/59 (6.78%) 
Investigations   
Alanine aminotransferase increased  1  11/59 (18.64%) 
Alkaline phosphatase increased  1  6/59 (10.17%) 
Aspartate aminotransferase increased  1  19/59 (32.20%) 
Blood bilirubin increased  1  6/59 (10.17%) 
CD4 lymphocytes decreased  1  3/59 (5.08%) 
Creatinine increased  1  21/59 (35.59%) 
Platelet count decreased  1  36/59 (61.02%) 
Weight loss  1  8/59 (13.56%) 
Metabolism and nutrition disorders   
Hyperglycemia  1  7/59 (11.86%) 
Hyperkalemia  1  3/59 (5.08%) 
Hypoalbuminemia  1  12/59 (20.34%) 
Hypocalcemia  1  7/59 (11.86%) 
Hypomagnesemia  1  4/59 (6.78%) 
Hyponatremia  1  5/59 (8.47%) 
Musculoskeletal and connective tissue disorders   
Myalgia  1  4/59 (6.78%) 
Nervous system disorders   
Dysesthesia  1  6/59 (10.17%) 
Dysgeusia  1  27/59 (45.76%) 
Headache  1  6/59 (10.17%) 
Paresthesia  1  4/59 (6.78%) 
Renal and urinary disorders   
Hemoglobinuria  1  3/59 (5.08%) 
Proteinuria  1  23/59 (38.98%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  12/59 (20.34%) 
Epistaxis  1  8/59 (13.56%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  3/59 (5.08%) 
Dry skin  1  4/59 (6.78%) 
Hand-foot syndrome  1  32/59 (54.24%) 
Rash  1  24/59 (40.68%) 
Pruritus  1  8/59 (13.56%) 
Hair hypopigmentation  1  4/59 (6.78%) 
Skin hypopigmentation  1  12/59 (20.34%) 
Vascular disorders   
Hypertension  1  10/59 (16.95%) 
Thromboembolic event  1  3/59 (5.08%) 
1
Term from vocabulary, CTCAE version 4
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: Dr. Eric Jonasch, MD/Professor, Genitourinary Medical Oncology
Organization: University of Texas MD Anderson Cancer Center
Phone: 713-792-2830
EMail: ejonasch@mdanderson.org
Layout table for additonal information
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02060370    
Other Study ID Numbers: 2013-0944
NCI-2014-01908 ( Registry Identifier: NCI CTRP )
First Submitted: February 10, 2014
First Posted: February 12, 2014
Results First Submitted: January 2, 2020
Results First Posted: February 27, 2020
Last Update Posted: February 27, 2020