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

NCT00808639 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2016-10-24

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Toni Choueiri, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2013-12-31
Completion
2016-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00808639 on ClinicalTrials.gov