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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:
ClinicalTrials.gov Identifier:
NCT01916109
First Posted: August 5, 2013
Last Update Posted: February 12, 2016
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.
Collaborator:
Amgen
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
Results First Submitted: January 14, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (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) 
Overall Participants Analyzed 
[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
First Submitted: August 2, 2013
First Posted: August 5, 2013
Results First Submitted: January 14, 2016
Results First Posted: February 12, 2016
Last Update Posted: February 12, 2016