Trial Outcomes & Findings for Sunitinib in Treating Patients With Kidney Cancer That Cannot Be Removed by Surgery (NCT NCT00459979)
NCT ID: NCT00459979
Last Updated: 2014-03-07
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
1 year from start of treatment
Results posted on
2014-03-07
Participant Flow
Participant milestones
| Measure |
Sunitinib
sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily
conventional surgery : nephrectomy
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Sunitinib
sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily
conventional surgery : nephrectomy
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Sunitinib in Treating Patients With Kidney Cancer That Cannot Be Removed by Surgery
Baseline characteristics by cohort
| Measure |
Sunitinib
n=30 Participants
sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily
conventional surgery : nephrectomy
|
|---|---|
|
Age, Continuous
Median age
|
61 Years
FULL_RANGE 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 year from start of treatmentPopulation: per protocol - analysis after at least one cycle of Sunitinib
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
Outcome measures
| Measure |
Sunitinib
n=28 Participants
sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily
conventional surgery : nephrectomy
|
|---|---|
|
Response to Sunitinib Therapy
|
13 participants
|
SECONDARY outcome
Timeframe: 1 year from start of treatmentThe 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.
Outcome measures
| Measure |
Sunitinib
n=28 Participants
sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily
conventional surgery : nephrectomy
|
|---|---|
|
The Number of Patients With Any Type of Complication or Adverse Event
|
28 participants
|
SECONDARY outcome
Timeframe: 1 year from start of treatmentProgression 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.
Outcome measures
| Measure |
Sunitinib
n=28 Participants
sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily
conventional surgery : nephrectomy
|
|---|---|
|
Progression Free Survival
|
11.2 months
Interval 1.7 to 36.5
|
SECONDARY outcome
Timeframe: 1 year from start of treatmentPopulation: per protocol - analysis after at least one cycle of Sunitinib
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.
Outcome measures
| Measure |
Sunitinib
n=35 tumors
sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily
conventional surgery : nephrectomy
|
|---|---|
|
Percent Decrease of Diameter of Primary Tumors
|
22 percentage of tumors diameter decrease
Interval -13.0 to 100.0
|
SECONDARY outcome
Timeframe: 1 year from start of treatmentPopulation: per protocol - after at lease one cycle of Sunitinib
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.
Outcome measures
| Measure |
Sunitinib
n=35 tumors
sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily
conventional surgery : nephrectomy
|
|---|---|
|
Number of Tumors Which Decreased in Size
|
28 tumors
|
SECONDARY outcome
Timeframe: 1 year from start of treatmentPopulation: per protocol- after at least one cycle of Sunitinib
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.
Outcome measures
| Measure |
Sunitinib
n=35 tumors
sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily
conventional surgery : nephrectomy
|
|---|---|
|
Number of Tumors With 30% Reduction in Size
|
13 tumors
|
SECONDARY outcome
Timeframe: 1 year from start of treatmentThe median size reduction in the largest diameter of the primary RCC tumor among the tumors with at least some shrinkage in diameter
Outcome measures
| Measure |
Sunitinib
n=28 tumors with size reduction
sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily
conventional surgery : nephrectomy
|
|---|---|
|
Median Size Reduction Among Tumors With Some Shrinkage
|
1.6 cm
Interval 0.4 to 5.1
|
Adverse Events
Sunitinib
Serious events: 16 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sunitinib
n=28 participants at risk
sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily
conventional surgery : nephrectomy
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
14.3%
4/28
|
|
Blood and lymphatic system disorders
Platelets
|
3.6%
1/28
|
|
Blood and lymphatic system disorders
Supraventricular and nodal arrhythmia - Atrial fibrillation
|
7.1%
2/28
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
3.6%
1/28
|
|
Vascular disorders
Hypotension
|
3.6%
1/28
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
3.6%
1/28
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
3.6%
1/28
|
|
General disorders
Death not associated with CTCAE term - Disease progression NOS
|
7.1%
2/28
|
|
Metabolism and nutrition disorders
Dehydration
|
3.6%
1/28
|
|
Gastrointestinal disorders
Perforated Bowel
|
3.6%
1/28
|
|
Gastrointestinal disorders
Obstruction, GI - Small bowel NOS
|
3.6%
1/28
|
|
Reproductive system and breast disorders
Hemorrhage, GU - Urinary NOS
|
10.7%
3/28
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Respiratory tract NOS
|
3.6%
1/28
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS
|
3.6%
1/28
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
3.6%
1/28
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
10.7%
3/28
|
|
General disorders
"Pain - NOS
|
3.6%
1/28
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain - Tumor pain
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
10.7%
3/28
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
7.1%
2/28
|
|
Renal and urinary disorders
Obstruction, GU - Bladder
|
3.6%
1/28
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
21.4%
6/28
|
Other adverse events
| Measure |
Sunitinib
n=28 participants at risk
sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily
conventional surgery : nephrectomy
|
|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
60.7%
17/28
|
|
Investigations
Leukocytes (total WBC)
|
42.9%
12/28
|
|
Investigations
Lymphopenia
|
14.3%
4/28
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
42.9%
12/28
|
|
Investigations
Platelets
|
78.6%
22/28
|
|
Vascular disorders
Hypertension
|
50.0%
14/28
|
|
Vascular disorders
Hypotension
|
14.3%
4/28
|
|
General disorders
Constitutional Symptoms - Other (Specify, __)
|
17.9%
5/28
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
85.7%
24/28
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC <1.0 x 10e9/L)
|
7.1%
2/28
|
|
General disorders
Insomnia
|
10.7%
3/28
|
|
General disorders
Weight loss
|
14.3%
4/28
|
|
Skin and subcutaneous tissue disorders
Cheilitis
|
14.3%
4/28
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
39.3%
11/28
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
32.1%
9/28
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
21.4%
6/28
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
10.7%
3/28
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
46.4%
13/28
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
|
28.6%
8/28
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
67.9%
19/28
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
46.4%
13/28
|
|
Gastrointestinal disorders
Anorexia
|
57.1%
16/28
|
|
Gastrointestinal disorders
Constipation
|
64.3%
18/28
|
|
Gastrointestinal disorders
Dehydration
|
17.9%
5/28
|
|
Gastrointestinal disorders
Diarrhea
|
82.1%
23/28
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
7.1%
2/28
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
10.7%
3/28
|
|
Gastrointestinal disorders
Gastrointestinal - Other (Specify, __)
|
10.7%
3/28
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
42.9%
12/28
|
|
Gastrointestinal disorders
Hemorrhoids
|
21.4%
6/28
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam) - Oral cavity
|
25.0%
7/28
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic) - Oral cavity
|
71.4%
20/28
|
|
Gastrointestinal disorders
Nausea
|
60.7%
17/28
|
|
Gastrointestinal disorders
Taste alteration (dysgeusia)
|
67.9%
19/28
|
|
Gastrointestinal disorders
Vomiting
|
42.9%
12/28
|
|
Vascular disorders
Hematoma
|
7.1%
2/28
|
|
Gastrointestinal disorders
Hemorrhage, GI - Oral cavity
|
7.1%
2/28
|
|
Gastrointestinal disorders
Hemorrhage, GI - Rectum
|
21.4%
6/28
|
|
Renal and urinary disorders
Hemorrhage, GU - Urinary NOS
|
17.9%
5/28
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
28.6%
8/28
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Respiratory tract NOS
|
10.7%
3/28
|
|
Vascular disorders
Hemorrhage/Bleeding - Other
|
7.1%
2/28
|
|
Skin and subcutaneous tissue disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
10.7%
3/28
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Upper airway NOS
|
7.1%
2/28
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS
|
25.0%
7/28
|
|
Infections and infestations
Infection with unknown ANC - Dental-tooth
|
7.1%
2/28
|
|
Infections and infestations
Infection with unknown ANC - Pharynx
|
14.3%
4/28
|
|
Blood and lymphatic system disorders
Edema: head and neck
|
14.3%
4/28
|
|
Blood and lymphatic system disorders
Edema: limb
|
7.1%
2/28
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
10.7%
3/28
|
|
Investigations
Alkaline phosphatase
|
7.1%
2/28
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
32.1%
9/28
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
42.9%
12/28
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
10.7%
3/28
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
7.1%
2/28
|
|
Investigations
Creatinine
|
39.3%
11/28
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
14.3%
4/28
|
|
Metabolism and nutrition disorders
Glucose, serum-low (hypoglycemia)
|
7.1%
2/28
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
14.3%
4/28
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
10.7%
3/28
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
10.7%
3/28
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
21.4%
6/28
|
|
Musculoskeletal and connective tissue disorders
Uric acid, serum-high (hyperuricemia)
|
10.7%
3/28
|
|
Nervous system disorders
Dizziness
|
35.7%
10/28
|
|
Nervous system disorders
Neuropathy: sensory
|
10.7%
3/28
|
|
Nervous system disorders
Syncope (fainting)
|
7.1%
2/28
|
|
Gastrointestinal disorders
Pain - Abdomen NOS
|
32.1%
9/28
|
|
Musculoskeletal and connective tissue disorders
Pain - Back
|
14.3%
4/28
|
|
Musculoskeletal and connective tissue disorders
Pain - Chest wall
|
7.1%
2/28
|
|
Gastrointestinal disorders
Pain - Dental/teeth/peridontal
|
7.1%
2/28
|
|
Musculoskeletal and connective tissue disorders
Pain - Extremity-limb
|
42.9%
12/28
|
|
Nervous system disorders
Pain - Head/headache
|
28.6%
8/28
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
17.9%
5/28
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
14.3%
4/28
|
|
Gastrointestinal disorders
Pain - Oral cavity
|
10.7%
3/28
|
|
General disorders
Pain - Other (Specify, __)
|
7.1%
2/28
|
|
Gastrointestinal disorders
Pain - Rectum
|
21.4%
6/28
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.7%
3/28
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
21.4%
6/28
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
7.1%
2/28
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
10.7%
3/28
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis)
|
7.1%
2/28
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place