Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Gemcitabine, Cisplatin, and Sunitinib (GC-S) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer

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: NCT00847015
Recruitment Status : Completed
First Posted : February 19, 2009
Results First Posted : February 29, 2016
Last Update Posted : February 29, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Bladder Cancer
Urinary Bladder
Interventions Drug: Sunitinib
Drug: Gemcitabine
Drug: cisplatin
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gemcitabine, Cisplatin, and Sunitinib
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 18
Completed 15
Not Completed 3
Reason Not Completed
Withdrawal by Subject             1
declined any surgery             1
partial cystectomy vs radical cystectomy             1
Arm/Group Title Gemcitabine, Cisplatin, and Sunitinib
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  61.1%
>=65 years
7
  38.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
3
  16.7%
Male
15
  83.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title The Pathologic Complete Response Rate (<pT0) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer.
Hide Description 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.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemcitabine, Cisplatin, and Sunitinib
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6.67
(.34 to 29.8)
2.Secondary Outcome
Title The Pathologic Response Rate (<pT2) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer.
Hide Description is defined as the absence of muscle invasive carcinoma (<pT2 disease) and the absence of microscopic lymph node metastases (N0) on the final cystectomy specimen.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemcitabine, Cisplatin, and Sunitinib
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
33
(15 to 58)
3.Secondary Outcome
Title The Time to Disease Progression in Patients With Muscle Invasive Urothelial Carcinoma of the Bladder Treated With Neoadjuvant GCS Followed by Radical Cystectomy.
Hide Description The 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.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemcitabine, Cisplatin, and Sunitinib
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 15
Median (95% Confidence Interval)
Unit of Measure: months
10 [1] 
(3.5 to NA)
[1]
This number could not be calculated as three participants are deceased.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gemcitabine, Cisplatin, and Sunitinib
Hide Arm/Group Description

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.

All-Cause Mortality
Gemcitabine, Cisplatin, and Sunitinib
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Gemcitabine, Cisplatin, and Sunitinib
Affected / at Risk (%) # Events
Total   14/18 (77.78%)    
Blood and lymphatic system disorders   
Febrile Neutropenia  1  2/18 (11.11%)  2
Anemia  2  2/18 (11.11%)  2
General disorders   
Fever  2  2/18 (11.11%)  2
Infections and infestations   
Wound infection  2  1/18 (5.56%)  1
Skin infection  2  1/18 (5.56%)  1
Investigations   
Neutrophil count decrease  2  1/18 (5.56%)  1
Platelet count decreased  2  4/18 (22.22%)  5
Metabolism and nutrition disorders   
Hyponatremia  2  1/18 (5.56%)  1
Dehydration  2  1/18 (5.56%)  1
Nervous system disorders   
Syncope  2  1/18 (5.56%)  1
Vascular disorders   
Hypotension  2  1/18 (5.56%)  1
Thrombosis  2  2/18 (11.11%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, ctcae 3.0
2
Term from vocabulary, CTCAE (3.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gemcitabine, Cisplatin, and Sunitinib
Affected / at Risk (%) # Events
Total   18/18 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  11/18 (61.11%)  11
Febrile Neutropenia  1  2/18 (11.11%)  2
Cardiac disorders   
Leukocytes (total WBC)  1  6/18 (33.33%)  25
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  2/18 (11.11%)  2
Infections and infestations   
Infection  1  2/18 (11.11%)  2
Investigations   
Neutrophil count decreased  1  6/18 (33.33%)  6
Lymphopenia  1  3/18 (16.67%)  5
Neutrophils/granulocytes (ANC/AGC)  1  6/18 (33.33%)  34
Platelets  1  6/18 (33.33%)  16
Metabolism and nutrition disorders   
Glucose, high (hyperglycemia)  1  8/18 (44.44%)  18
Magnesium, low (hypomagnesemia)  1  2/18 (11.11%)  3
Potassium, high (hyperkalemia)  1  2/18 (11.11%)  3
Renal and urinary disorders   
Urinary frequency/urgency  1  5/18 (27.78%)  7
Vascular disorders   
Thrombotic events  1  2/18 (11.11%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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. M. Catherine Pietanza
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-4203
EMail: pietanzm@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00847015    
Other Study ID Numbers: 08-159
First Submitted: February 18, 2009
First Posted: February 19, 2009
Results First Submitted: October 19, 2015
Results First Posted: February 29, 2016
Last Update Posted: February 29, 2016