Dose-Dense MVAC With Pegfilgrastim Support in Subjects With Muscle-Invasive Urothelial Carcinoma
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ClinicalTrials.gov Identifier: NCT00808639 |
Recruitment Status :
Completed
First Posted : December 16, 2008
Results First Posted : May 15, 2014
Last Update Posted : October 24, 2016
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Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Amgen
Information provided by (Responsible Party):
Toni Choueiri, MD, Dana-Farber Cancer Institute
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Bladder Cancer Muscle-invasive Bladder Cancer |
Interventions |
Drug: Methotrexate Drug: Doxorubicin Drug: vinblastine Drug: cisplatin Drug: Pegfilgrastim |
Enrollment | 39 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Dose Dense MVAC |
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Dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) |
Period Title: Overall Study | |
Started | 39 |
Completed | 38 [1] |
Not Completed | 1 |
Reason Not Completed | |
Disease progression before surgery. | 1 |
[1]
One patient went off treatment due to disease progression before surgery.
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Baseline Characteristics
Arm/Group Title | Dose Dense MVAC | |
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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 |
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Overall Number of Baseline Participants | 39 | |
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[Not Specified]
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Age, Continuous
Median (Full Range) Unit of measure: Years |
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Number Analyzed | 39 participants | |
57
(43 to 76)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 39 participants | |
Female |
11 28.2%
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Male |
28 71.8%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 39 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
0 0.0%
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White |
39 100.0%
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More than one race |
0 0.0%
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Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 39 participants |
39 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Toni Choueiri, MD |
Organization: | Dana-Farber Cancer Institute |
Phone: | 617-632-5456 |
EMail: | 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 |
Other Study ID Numbers: |
08-208 |
First Submitted: | December 15, 2008 |
First Posted: | December 16, 2008 |
Results First Submitted: | January 14, 2014 |
Results First Posted: | May 15, 2014 |
Last Update Posted: | October 24, 2016 |