Study of Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer

This study has been terminated.
(Lack of accrual)
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01916109
First received: August 2, 2013
Last updated: January 14, 2016
Last verified: January 2016
Results First Received: January 14, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Bladder Cancer
Interventions: Drug: Gemcitabine
Drug: Carboplatin
Drug: Panitumumab
Procedure: radical cystectomy

  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
No text entered.

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, Carboplatin, and Panitumumab (GCaP) Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer

Participant Flow:   Overall Study
    Gemcitabine, Carboplatin, and Panitumumab (GCaP)  
STARTED     4  
COMPLETED     3  
NOT COMPLETED     1  
Withdrawal by Subject                 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, Carboplatin, and Panitumumab (GCaP) Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer

Baseline Measures
    Gemcitabine, Carboplatin, and Panitumumab (GCaP)  
Number of Participants  
[units: participants]
  4  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     4  
Gender  
[units: participants]
 
Female     0  
Male     4  



  Outcome Measures

1.  Primary:   Pathologic Complete Response Rate (<pT0)   [ Time Frame: 1 year ]


  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. Dean Bajorin
Organization: Memorial Sloan Kettering Cancer Center
phone: 646-422-4333
e-mail: bajorind@mskcc.org



Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01916109     History of Changes
Other Study ID Numbers: 10-103
Study First Received: August 2, 2013
Results First Received: January 14, 2016
Last Updated: January 14, 2016
Health Authority: United States: Food and Drug Administration