The purpose of this research study is to test the effectiveness of neoadjuvant dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC) in combination with pegfilgrastim followed by radical surgery in patients 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
intravenously 30mg/m2 over 30 minutes
intravenously 30mg/ms over 15 minutes
intravenously 3mg/m2 over 30 minutes
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Lahey Clinic
Burlington, Massachusetts, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Number of Patients Achieving Pathologic Response
Pathological response is defined as down-staging to \</=pT1, N0 after chemotherapy with pegfilgrastim support.
Time frame: After completion of 4 cycles of chemotherapy with pegfilgrastim support (cycle length 2 weeks)
Number of Patients Experiencing Febrile Neutropenia
Febrile neutropenia defined per CTCAEv3 as Grade 3 or higher and treatment attribution possibly, probably or definitely-related.
Time frame: After completion of 4 cycles of chemotherapy with pegfilgrastim support (cycle length 2 weeks)
Number of Patients Experiencing Surgery-related Toxicity
Surgery-related toxicity defined per CTCAEv3 as Grade 2 or higher and treatment attribution possibly, probably or definitely-related.
Time frame: Surgery + 30 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion
Given subcutaneously 24 hours after last chemotherapy dose