Trial Outcomes & Findings for Bacillus Calmette-Guerin Followed by Sunitinib for the Treatment of High Risk Non-muscle Invasive Lower Urinary Tract Urothelial Carcinoma (NCT NCT00794950)
NCT ID: NCT00794950
Last Updated: 2019-09-23
Results Overview
Complete response is defined as no evidence of cancer on bladder biopsy or on a urine test that looks for cancer cells (cytology)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
14 weeks
Results posted on
2019-09-23
Participant Flow
Participant milestones
| Measure |
Sunitinib Treatment
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.
|
|---|---|
|
BCG Induction
STARTED
|
43
|
|
BCG Induction
COMPLETED
|
36
|
|
BCG Induction
NOT COMPLETED
|
7
|
|
Beginning Sunitinib Treatment
STARTED
|
36
|
|
Beginning Sunitinib Treatment
COMPLETED
|
24
|
|
Beginning Sunitinib Treatment
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Sunitinib Treatment
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.
|
|---|---|
|
BCG Induction
Withdrawal by Subject
|
2
|
|
BCG Induction
ineligible
|
3
|
|
BCG Induction
noncompliant w. BCG
|
1
|
|
BCG Induction
Adverse Event
|
1
|
|
Beginning Sunitinib Treatment
cystectomy
|
5
|
|
Beginning Sunitinib Treatment
Physician Decision
|
5
|
|
Beginning Sunitinib Treatment
Withdrawal by Subject
|
1
|
|
Beginning Sunitinib Treatment
Lost to Follow-up
|
1
|
Baseline Characteristics
Bacillus Calmette-Guerin Followed by Sunitinib for the Treatment of High Risk Non-muscle Invasive Lower Urinary Tract Urothelial Carcinoma
Baseline characteristics by cohort
| Measure |
Sunitinib Treatment
n=36 Participants
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.
|
|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 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
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
ECOG performance
0
|
33 Participants
n=5 Participants
|
|
ECOG performance
1
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 14 weeksComplete response is defined as no evidence of cancer on bladder biopsy or on a urine test that looks for cancer cells (cytology)
Outcome measures
| Measure |
Sunitinib Treatment
n=36 Participants
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.
|
|---|---|
|
Number of Participants With Complete Response at 3 Months
|
26 Participants
|
SECONDARY outcome
Timeframe: 28 weeksComplete response is defined as no evidence of cancer on bladder biopsy or on a urine test that looks for cancer cells (cytology)
Outcome measures
| Measure |
Sunitinib Treatment
n=36 Participants
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.
|
|---|---|
|
Percentage of Participants Who Experienced a Complete Response at 6 Months, Following Study Regimen.
|
27 Participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Sunitinib Treatment
n=36 Participants
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.
|
|---|---|
|
Recurrence-free Survival at 2 Years in Patients With Intact Bladder.
|
77 percentage of participants
Interval 58.0 to 88.0
|
SECONDARY outcome
Timeframe: 26 monthsPopulation: All participants were followed, by permission, even those who withdrew from full treatment.
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.
Outcome measures
| Measure |
Sunitinib Treatment
n=36 Participants
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.
|
|---|---|
|
Number of Participants With Toxicity Related to Treatment With BCG Followed by Sunitinib
No Toxicity of Grade 3 or higher
|
31 Participants
|
|
Number of Participants With Toxicity Related to Treatment With BCG Followed by Sunitinib
3: Gastrointestinal: febrile diarrhea
|
1 Participants
|
|
Number of Participants With Toxicity Related to Treatment With BCG Followed by Sunitinib
3: Blood and Lymphatic: Thrombocytopenia
|
1 Participants
|
|
Number of Participants With Toxicity Related to Treatment With BCG Followed by Sunitinib
3: S & S: rash on hands, feet
|
1 Participants
|
|
Number of Participants With Toxicity Related to Treatment With BCG Followed by Sunitinib
3: S & S: hand & foot syndrome
|
1 Participants
|
|
Number of Participants With Toxicity Related to Treatment With BCG Followed by Sunitinib
3 S & S: sores on hands & ft; infection: shingles
|
1 Participants
|
Adverse Events
Sunitinib Treatment
Serious events: 5 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sunitinib Treatment
n=36 participants at risk
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.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash on Hands/Feet
|
2.8%
1/36 • 26 months
|
|
Skin and subcutaneous tissue disorders
Hand/Foot Syndrome
|
2.8%
1/36 • 26 months
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
2.8%
1/36 • 26 months
|
|
Gastrointestinal disorders
febrile diarrhea
|
2.8%
1/36 • 26 months
|
|
Skin and subcutaneous tissue disorders
Sores on Hands/feet
|
2.8%
1/36 • 26 months
|
|
Infections and infestations
shingles; zoster reactivation
|
2.8%
1/36 • 26 months
|
Other adverse events
| Measure |
Sunitinib Treatment
n=36 participants at risk
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.
|
|---|---|
|
Renal and urinary disorders
Acute Renal Failure
|
2.8%
1/36 • 26 months
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
12/36 • 26 months
|
|
Vascular disorders
Hypertension
|
44.4%
16/36 • 26 months
|
|
Blood and lymphatic system disorders
Thrombocytopenic
|
19.4%
7/36 • 26 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
2/36 • 26 months
|
|
Hepatobiliary disorders
Jaundice
|
16.7%
6/36 • 26 months
|
|
Gastrointestinal disorders
Nausea
|
30.6%
11/36 • 26 months
|
|
Respiratory, thoracic and mediastinal disorders
Epislaxis
|
5.6%
2/36 • 26 months
|
|
Nervous system disorders
Lightheadedness
|
5.6%
2/36 • 26 months
|
|
Renal and urinary disorders
Hematuria
|
5.6%
2/36 • 26 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.8%
1/36 • 26 months
|
|
General disorders
Fatigue
|
58.3%
21/36 • 26 months
|
|
General disorders
Edema
|
11.1%
4/36 • 26 months
|
|
General disorders
Cough
|
8.3%
3/36 • 26 months
|
|
General disorders
hand and foot pain
|
11.1%
4/36 • 26 months
|
|
Infections and infestations
Urinary Tract Infection
|
16.7%
6/36 • 26 months
|
|
Gastrointestinal disorders
Sores in mouth
|
25.0%
9/36 • 26 months
|
|
Gastrointestinal disorders
Gastritis
|
11.1%
4/36 • 26 months
|
|
Investigations
Bilirubin increased
|
16.7%
6/36 • 26 months
|
|
Investigations
Elevated transminases
|
8.3%
3/36 • 26 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
2/36 • 26 months
|
|
Nervous system disorders
Dysgeusia
|
5.6%
2/36 • 26 months
|
|
Nervous system disorders
Headache
|
5.6%
2/36 • 26 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.6%
2/36 • 26 months
|
|
Vascular disorders
Hypotension
|
2.8%
1/36 • 26 months
|
|
Vascular disorders
Flushing
|
2.8%
1/36 • 26 months
|
|
Skin and subcutaneous tissue disorders
Petachiae
|
2.8%
1/36 • 26 months
|
|
Renal and urinary disorders
Epidymitis
|
2.8%
1/36 • 26 months
|
|
Cardiac disorders
Sinus tachycardia
|
2.8%
1/36 • 26 months
|
|
Gastrointestinal disorders
Constipation
|
2.8%
1/36 • 26 months
|
|
Gastrointestinal disorders
Dyspepsia
|
2.8%
1/36 • 26 months
|
|
Gastrointestinal disorders
Acid reflux
|
2.8%
1/36 • 26 months
|
|
Gastrointestinal disorders
Rectal bleeding
|
2.8%
1/36 • 26 months
|
|
Gastrointestinal disorders
Gastrointestinal cramping
|
2.8%
1/36 • 26 months
|
|
General disorders
Chills
|
2.8%
1/36 • 26 months
|
|
Nervous system disorders
Peripheral Neuropathy
|
2.8%
1/36 • 26 months
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
2.8%
1/36 • 26 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place