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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00847015
First received: February 18, 2009
Last updated: February 1, 2016
Last verified: February 2016
Results First Received: October 19, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Bladder Cancer
Urinary Bladder
Interventions: Drug: Sunitinib
Drug: Gemcitabine
Drug: cisplatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Gemcitabine, Cisplatin, and Sunitinib  
STARTED     18  
COMPLETED     15  
NOT COMPLETED     3  
Withdrawal by Subject                 1  
declined any surgery                 1  
partial cystectomy vs radical cystectomy                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.


Baseline Measures
    Gemcitabine, Cisplatin, and Sunitinib  
Number of Participants  
[units: participants]
  18  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     11  
>=65 years     7  
Gender  
[units: participants]
 
Female     3  
Male     15  
Region of Enrollment  
[units: participants]
 
United States     18  



  Outcome Measures
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1.  Primary:   The Pathologic Complete Response Rate (<pT0) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer.   [ Time Frame: 2 years ]

2.  Secondary:   The Pathologic Response Rate (<pT2) of Neoadjuvant GCS Regimen in Patients With Muscle-invasive Bladder Cancer.   [ Time Frame: 2 years ]

3.  Secondary:   The Time to Disease Progression in Patients With Muscle Invasive Urothelial Carcinoma of the Bladder Treated With Neoadjuvant GCS Followed by Radical Cystectomy.   [ Time Frame: 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. M. Catherine Pietanza
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-888-4203
e-mail: pietanzm@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00847015     History of Changes
Other Study ID Numbers: 08-159
Study First Received: February 18, 2009
Results First Received: October 19, 2015
Last Updated: February 1, 2016
Health Authority: United States: Institutional Review Board