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Bacillus Calmette-Guerin Followed by Sunitinib for the Treatment of High Risk Non-muscle Invasive Lower Urinary Tract Urothelial Carcinoma (Sutent)

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ClinicalTrials.gov Identifier: NCT00794950
Recruitment Status : Completed
First Posted : November 21, 2008
Results First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Alon Weizer, University of Michigan

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Urinary Tract Urothelial Carcinoma
Intervention Drug: Sunitinib
Enrollment 43
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sunitinib Treatment
Hide Arm/Group Description

Intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma.

Sunitinib: Patients are treated with a 6-week induction course of intravesical bacillus Calmette-Guerin (BCG) followed by a 2 week rest period and 4 week course of oral Sunitinib.

Patients will receive intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma. Two weeks after completion of BCG, patients will receive Sunitinib (50 mg daily) continuously for 28 days followed by a two week rest period. Patients will be reassessed with transurethral resection and urine cytology. Those with residual/recurrent disease will receive a second course identical to the initial protocol. Those with a complete response following initial or second treatment will be placed on maintenance BCG.

Period Title: BCG Induction
Started 43
Completed 36
Not Completed 7
Reason Not Completed
Withdrawal by Subject             2
ineligible             3
noncompliant w. BCG             1
Adverse Event             1
Period Title: Beginning Sunitinib Treatment
Started 36
Completed 24
Not Completed 12
Reason Not Completed
cystectomy             5
Physician Decision             5
Withdrawal by Subject             1
Lost to Follow-up             1
Arm/Group Title Sunitinib Treatment
Hide Arm/Group Description

Intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma.

Sunitinib: Patients are treated with a 6-week induction course of intravesical bacillus Calmette-Guerin (BCG) followed by a 2 week rest period and 4 week course of oral Sunitinib.

Patients will receive intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma. Two weeks after completion of BCG, patients will receive Sunitinib (50 mg daily) continuously for 28 days followed by a two week rest period. Patients will be reassessed with transurethral resection and urine cytology. Those with residual/recurrent disease will receive a second course identical to the initial protocol. Those with a complete response following initial or second treatment will be placed on maintenance BCG.

Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
Only participants who were able to begin sunitinib treatment were analyzable and therefore are included here.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 36 participants
66
(57 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
6
  16.7%
Male
30
  83.3%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 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
   2.8%
White
28
  77.8%
More than one race
0
   0.0%
Unknown or Not Reported
7
  19.4%
ECOG performance   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
0
33
  91.7%
1
3
   8.3%
[1]
Measure Description: Eastern Cooperative Oncology Group (ECOG) scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living activities of the patient. It goes from 0 to 5, with 0 being no interference with ordinary living and 5 being dead
1.Primary Outcome
Title Number of Participants With Complete Response at 3 Months
Hide Description Complete response is defined as no evidence of cancer on bladder biopsy or on a urine test that looks for cancer cells (cytology)
Time Frame 14 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sunitinib Treatment
Hide Arm/Group Description:

Intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma.

Sunitinib: Patients are treated with a 6-week induction course of intravesical bacillus Calmette-Guerin (BCG) followed by a 2 week rest period and 4 week course of oral Sunitinib. Patients will receive intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma. Two weeks after completion of BCG, patients will receive Sunitinib (50 mg daily) continuously for 28 days followed by a two week rest period. Patients will be reassessed with transurethral resection and urine cytology. Those with residual/recurrent disease will receive a second course identical to the initial protocol. Those with a complete response following initial or second treatment will be placed on maintenance BCG.

Overall Number of Participants Analyzed 36
Measure Type: Count of Participants
Unit of Measure: Participants
26
  72.2%
2.Secondary Outcome
Title Percentage of Participants Who Experienced a Complete Response at 6 Months, Following Study Regimen.
Hide Description Complete response is defined as no evidence of cancer on bladder biopsy or on a urine test that looks for cancer cells (cytology)
Time Frame 28 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sunitinib Treatment
Hide Arm/Group Description:

Intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma.

Sunitinib: Patients are treated with a 6-week induction course of intravesical bacillus Calmette-Guerin (BCG) followed by a 2 week rest period and 4 week course of oral Sunitinib. Patients will receive intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma. Two weeks after completion of BCG, patients will receive Sunitinib (50 mg daily) continuously for 28 days followed by a two week rest period. Patients will be reassessed with transurethral resection and urine cytology. Those with residual/recurrent disease will receive a second course identical to the initial protocol. Those with a complete response following initial or second treatment will be placed on maintenance BCG.

Overall Number of Participants Analyzed 36
Measure Type: Count of Participants
Unit of Measure: Participants
27
  75.0%
3.Secondary Outcome
Title Recurrence-free Survival at 2 Years in Patients With Intact Bladder.
Hide Description [Not Specified]
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sunitinib Treatment
Hide Arm/Group Description:

Intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma.

Sunitinib: Patients are treated with a 6-week induction course of intravesical bacillus Calmette-Guerin (BCG) followed by a 2 week rest period and 4 week course of oral Sunitinib.

Patients will receive intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma. Two weeks after completion of BCG, patients will receive Sunitinib (50 mg daily) continuously for 28 days followed by a two week rest period. Patients will be reassessed with transurethral resection and urine cytology. Those with residual/recurrent disease will receive a second course identical to the initial protocol. Those with a complete response following initial or second treatment will be placed on maintenance BCG.

Overall Number of Participants Analyzed 36
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
77
(58 to 88)
4.Secondary Outcome
Title Number of Participants With Toxicity Related to Treatment With BCG Followed by Sunitinib
Hide Description

Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used to characterize the toxicity: Toxic events are listed by name, body system and grade.

Note: to fit within character length constraints, "3" below means Grade 3; and S & S means Skin and Subcutaneous system.

Time Frame 26 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were followed, by permission, even those who withdrew from full treatment.
Arm/Group Title Sunitinib Treatment
Hide Arm/Group Description:

Intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma.

Sunitinib: Patients are treated with a 6-week induction course of intravesical bacillus Calmette-Guerin (BCG) followed by a 2 week rest period and 4 week course of oral Sunitinib. Patients will receive intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma. Two weeks after completion of BCG, patients will receive Sunitinib (50 mg daily) continuously for 28 days followed by a two week rest period. Patients will be reassessed with transurethral resection and urine cytology. Those with residual/recurrent disease will receive a second course identical to the initial protocol. Those with a complete response following initial or second treatment will be placed on maintenance BCG.

Overall Number of Participants Analyzed 36
Measure Type: Count of Participants
Unit of Measure: Participants
No Toxicity of Grade 3 or higher
31
  86.1%
3: Gastrointestinal: febrile diarrhea
1
   2.8%
3: Blood and Lymphatic: Thrombocytopenia
1
   2.8%
3: S & S: rash on hands, feet
1
   2.8%
3: S & S: hand & foot syndrome
1
   2.8%
3 S & S: sores on hands & ft; infection: shingles
1
   2.8%
Time Frame 26 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sunitinib Treatment
Hide Arm/Group Description

Intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma.

Sunitinib: Patients are treated with a 6-week induction course of intravesical bacillus Calmette-Guerin (BCG) followed by a 2 week rest period and 4 week course of oral Sunitinib.

Patients will receive intravesical BCG (81 mg Theracys BCG in 50 ml normal saline) once weekly for 6 weeks within 6 weeks of bladder biopsy confirming high risk non-muscle invasive urothelial carcinoma. Two weeks after completion of BCG, patients will receive Sunitinib (50 mg daily) continuously for 28 days followed by a 2 week rest period. Patients will be reassessed with transurethral resection and urine cytology. Those with residual/recurrent disease will receive a 2nd course identical to the initial protocol. Those with a complete response following initial or second treatment will be placed on maintenance BCG.

All-Cause Mortality
Sunitinib Treatment
Affected / at Risk (%)
Total   0/36 (0.00%) 
Hide Serious Adverse Events
Sunitinib Treatment
Affected / at Risk (%)
Total   5/36 (13.89%) 
Blood and lymphatic system disorders   
thrombocytopenia   1/36 (2.78%) 
Gastrointestinal disorders   
febrile diarrhea   1/36 (2.78%) 
Infections and infestations   
shingles; zoster reactivation   1/36 (2.78%) 
Skin and subcutaneous tissue disorders   
Rash on Hands/Feet   1/36 (2.78%) 
Hand/Foot Syndrome   1/36 (2.78%) 
Sores on Hands/feet   1/36 (2.78%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sunitinib Treatment
Affected / at Risk (%)
Total   34/36 (94.44%) 
Blood and lymphatic system disorders   
Thrombocytopenic   7/36 (19.44%) 
Cardiac disorders   
Sinus tachycardia   1/36 (2.78%) 
Gastrointestinal disorders   
Diarrhea   12/36 (33.33%) 
Nausea   11/36 (30.56%) 
Sores in mouth   9/36 (25.00%) 
Gastritis   4/36 (11.11%) 
Constipation   1/36 (2.78%) 
Dyspepsia   1/36 (2.78%) 
Acid reflux   1/36 (2.78%) 
Rectal bleeding   1/36 (2.78%) 
Gastrointestinal cramping   1/36 (2.78%) 
General disorders   
Fatigue   21/36 (58.33%) 
Edema   4/36 (11.11%) 
Cough   3/36 (8.33%) 
hand and foot pain   4/36 (11.11%) 
Chills   1/36 (2.78%) 
Hepatobiliary disorders   
Jaundice   6/36 (16.67%) 
Infections and infestations   
Urinary Tract Infection   6/36 (16.67%) 
Investigations   
Bilirubin increased   6/36 (16.67%) 
Elevated transminases   3/36 (8.33%) 
Metabolism and nutrition disorders   
Hyperglycemia   1/36 (2.78%) 
Musculoskeletal and connective tissue disorders   
Back pain   2/36 (5.56%) 
Nervous system disorders   
Lightheadedness   2/36 (5.56%) 
Dysgeusia   2/36 (5.56%) 
Headache   2/36 (5.56%) 
Peripheral Neuropathy   1/36 (2.78%) 
Renal and urinary disorders   
Hematuria   2/36 (5.56%) 
Epidymitis   1/36 (2.78%) 
Acute Renal Failure   1/36 (2.78%) 
Respiratory, thoracic and mediastinal disorders   
Epislaxis   2/36 (5.56%) 
dyspnea   1/36 (2.78%) 
Skin and subcutaneous tissue disorders   
Rash   2/36 (5.56%) 
Dry skin   2/36 (5.56%) 
Petachiae   1/36 (2.78%) 
Vascular disorders   
Hypertension   16/36 (44.44%) 
Hypotension   1/36 (2.78%) 
Flushing   1/36 (2.78%) 
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: Alon Z. Weizer, MD, MS
Organization: University of Michigan
Phone: 734-615-6662
EMail: aweizer@umich.edu
Layout table for additonal information
Responsible Party: Alon Weizer, University of Michigan
ClinicalTrials.gov Identifier: NCT00794950    
Other Study ID Numbers: Sutent V5 / November 9, 2009
First Submitted: November 20, 2008
First Posted: November 21, 2008
Results First Submitted: August 26, 2019
Results First Posted: September 23, 2019
Last Update Posted: September 23, 2019