NCT00808639

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

A Phase II Trial of Neoadjuvant Dose-Dense MVAC With Pegfilgrastim Support in Subjects With Muscle-Invasive Urothelial Carcinoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

* 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.

Conditions

• Bladder Cancer
• Muscle-invasive Bladder Cancer

Interventions

Type	Name	Description
DRUG	Methotrexate	intravenously 30mg/m2 over 30 minutes
DRUG	Doxorubicin	intravenously 30mg/ms over 15 minutes
DRUG	vinblastine	intravenously 3mg/m2 over 30 minutes
DRUG	cisplatin	intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion
DRUG	Pegfilgrastim	Given subcutaneously 24 hours after last chemotherapy dose

Timeline

• Start date: 2008-12-01
• Primary completion: 2013-12-01
• Completion: 2016-09-01
• First posted: 2008-12-16
• Last updated: 2016-10-24
• Results posted: 2014-05-15

Locations

4 sites across 1 country: United States