Trial Outcomes & Findings for Gemcitabine, Cisplatin, and Sunitinib (GC-S) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer (NCT NCT00847015)
NCT ID: NCT00847015
Last Updated: 2016-02-29
Results Overview
Complete pathologic response to neoadjuvant GCS is the primary endpoint is defined as the absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
2 years
Results posted on
2016-02-29
Participant Flow
Participant milestones
| Measure |
Gemcitabine, Cisplatin, and Sunitinib
This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.
Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8.
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|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Gemcitabine, Cisplatin, and Sunitinib
This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.
Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
declined any surgery
|
1
|
|
Overall Study
partial cystectomy vs radical cystectomy
|
1
|
Baseline Characteristics
Gemcitabine, Cisplatin, and Sunitinib (GC-S) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer
Baseline characteristics by cohort
| Measure |
Gemcitabine, Cisplatin, and Sunitinib
n=18 Participants
This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.
Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsComplete pathologic response to neoadjuvant GCS is the primary endpoint is defined as the absence of carcinoma (pT0 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.
Outcome measures
| Measure |
Gemcitabine, Cisplatin, and Sunitinib
n=15 Participants
This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.
Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8.
|
|---|---|
|
The Pathologic Complete Response Rate (<pT0) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer.
|
6.67 percentage of participants
Interval 0.34 to 29.8
|
SECONDARY outcome
Timeframe: 2 yearsis defined as the absence of muscle invasive carcinoma (\<pT2 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.
Outcome measures
| Measure |
Gemcitabine, Cisplatin, and Sunitinib
n=15 Participants
This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.
Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8.
|
|---|---|
|
The Pathologic Response Rate (<pT2) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer.
|
33 percentage of participants
Interval 15.0 to 58.0
|
SECONDARY outcome
Timeframe: 2 yearsThe time to disease progression is measured from the time of initiation of chemotherapy until the first date that systemic recurrence is objectively documented. Systemic recurrence for this trial is defined as either metastatic or local pelvic recurrence.
Outcome measures
| Measure |
Gemcitabine, Cisplatin, and Sunitinib
n=15 Participants
This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.
Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8.
|
|---|---|
|
The Time to Disease Progression in Patients With Muscle Invasive Urothelial Carcinoma of the Bladder Treated With Neoadjuvant GCS Followed by Radical Cystectomy.
|
10 months
Interval 3.5 to
This number could not be calculated as three participants are deceased.
|
Adverse Events
Gemcitabine, Cisplatin, and Sunitinib
Serious events: 14 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine, Cisplatin, and Sunitinib
n=18 participants at risk
This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.
Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
11.1%
2/18 • Number of events 2
|
|
General disorders
Fever
|
11.1%
2/18 • Number of events 2
|
|
Blood and lymphatic system disorders
Anemia
|
11.1%
2/18 • Number of events 2
|
|
Vascular disorders
Hypotension
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Wound infection
|
5.6%
1/18 • Number of events 1
|
|
Infections and infestations
Skin infection
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Neutrophil count decrease
|
5.6%
1/18 • Number of events 1
|
|
Investigations
Platelet count decreased
|
22.2%
4/18 • Number of events 5
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.6%
1/18 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
1/18 • Number of events 1
|
|
Nervous system disorders
Syncope
|
5.6%
1/18 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
11.1%
2/18 • Number of events 2
|
Other adverse events
| Measure |
Gemcitabine, Cisplatin, and Sunitinib
n=18 participants at risk
This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.
Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
61.1%
11/18 • Number of events 11
|
|
Investigations
Neutrophil count decreased
|
33.3%
6/18 • Number of events 6
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
11.1%
2/18 • Number of events 2
|
|
Vascular disorders
Thrombotic events
|
11.1%
2/18 • Number of events 2
|
|
Infections and infestations
Infection
|
11.1%
2/18 • Number of events 2
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
11.1%
2/18 • Number of events 2
|
|
Metabolism and nutrition disorders
Glucose, high (hyperglycemia)
|
44.4%
8/18 • Number of events 18
|
|
Cardiac disorders
Leukocytes (total WBC)
|
33.3%
6/18 • Number of events 25
|
|
Investigations
Lymphopenia
|
16.7%
3/18 • Number of events 5
|
|
Metabolism and nutrition disorders
Magnesium, low (hypomagnesemia)
|
11.1%
2/18 • Number of events 3
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
33.3%
6/18 • Number of events 34
|
|
Investigations
Platelets
|
33.3%
6/18 • Number of events 16
|
|
Metabolism and nutrition disorders
Potassium, high (hyperkalemia)
|
11.1%
2/18 • Number of events 3
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
27.8%
5/18 • Number of events 7
|
Additional Information
Dr. M. Catherine Pietanza
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4203
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place