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Dose-Dense MVAC With Pegfilgrastim Support in Subjects With Muscle-Invasive Urothelial Carcinoma

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Amgen
Information provided by (Responsible Party):
Toni Choueiri, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00808639
First received: December 15, 2008
Last updated: September 9, 2016
Last verified: September 2016
Results First Received: January 14, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Bladder Cancer
Muscle-invasive Bladder Cancer
Interventions: Drug: Methotrexate
Drug: Doxorubicin
Drug: vinblastine
Drug: cisplatin
Drug: Pegfilgrastim

  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
Dose Dense MVAC Dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC)

Participant Flow:   Overall Study
    Dose Dense MVAC
STARTED   39 
COMPLETED   38 [1] 
NOT COMPLETED   1 
Disease progression before surgery.                1 
[1] One patient went off treatment due to disease progression before surgery.



  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
Dose Dense MVAC

Methotrexate: intravenously 30mg/m2 over 30 minutes

Doxorubicin: intravenously 30mg/ms over 15 minutes

vinblastine: intravenously 3mg/m2 over 30 minutes

cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion

Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose


Baseline Measures
   Dose Dense MVAC 
Overall Participants Analyzed 
[Units: Participants]
 39 
Age 
[Units: Years]
Median (Full Range)
 57 
 (43 to 76) 
Gender 
[Units: Participants]
 
Female   11 
Male   28 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   0 
White   39 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   39 


  Outcome Measures
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1.  Primary:   Number of Patients Achieving Pathologic Response   [ Time Frame: After completion of 4 cycles of chemotherapy with pegfilgrastim support (cycle length 2 weeks) ]

2.  Secondary:   Number of Patients Experiencing Febrile Neutropenia   [ Time Frame: After completion of 4 cycles of chemotherapy with pegfilgrastim support (cycle length 2 weeks) ]

3.  Secondary:   Number of Patients Experiencing Surgery-related Toxicity   [ Time Frame: Surgery + 30 days ]


  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: Toni Choueiri, MD
Organization: Dana-Farber Cancer Institute
phone: 617-632-5456
e-mail: toni_choueiri@dfci.harvard.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Toni Choueiri, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00808639     History of Changes
Other Study ID Numbers: 08-208
Study First Received: December 15, 2008
Results First Received: January 14, 2014
Last Updated: September 9, 2016
Health Authority: United States: Institutional Review Board