A Phase II Trial of Neoadjuvant Dose-Dense MVAC With Pegfilgrastim Support in Subjects With Muscle-Invasive Urothelial Carcinoma
- Participants will be given a study infusion schedule for each treatment cycle. Each
treatment cycle lasts three weeks. The infusion of methotrexate will take place on the
first day of each cycle. Infusions of vinblastine, doxorubicin and cisplatin will take
place on the second day and an injection of pegfilgrastim will be given on the third
day.
- During all treatment cycles participants will have a physical exam and will be asked
questions about their general health and any problems they might be having and any
medications they may be taking.
- Following completion of study treatment, but before surgery, participants will have an
assessment of their tumor by CT scan of the chest and and MRI of the abdomen and
pelvis.
- Following the participants surgery, we would like to keep track of their medical
condition indefinitely, or until this study is officially completed. We would like to
do this by calling the participants on the telephone once a year to see how they are
doing.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To estimate the pathologic response of this patient population treated with neoadjuvant chemotherapy and pegfilgrastim followed by radical surgery with curative intent.
3 years
No
Toni Choueiri, MD
Principal Investigator
Dana-Farber Cancer Institute
United States: Institutional Review Board
08-208
NCT00808639
December 2008
December 2013
Name | Location |
---|---|
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
Lahey Clinic | Burlington, Massachusetts 01805 |