CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
Methotrexate +4 moredrug
Likely dose
Methotrexate 30mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00808639
NCT00808639Phase 2Completed
CompareCT.gov

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

Dana-Farber Cancer Institute·interventional·Posted Dec 16, 2008·Updated Oct 24, 2016

In Brief

A Phase 2 clinical trial evaluating Methotrexate, Doxorubicin, and 3 other interventions for Bladder Cancer and Muscle-invasive Bladder Cancer. Completed, enrolled 39 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer, Muscle-invasive Bladder Cancer
CountriesUnited States
CollaboratorsBeth Israel Deaconess Medical Center, Brigham and Women's Hospital, Amgen

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 16, 2008
Enrollment StartDec 1, 2008
Primary CompletionDec 1, 2013
Study CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 17.5 years ago

Interventions

Methotrexatedrug

intravenously 30mg/m2 over 30 minutes

Doxorubicindrug

intravenously 30mg/ms over 15 minutes

vinblastinedrug

intravenously 3mg/m2 over 30 minutes

cisplatindrug

intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion

Pegfilgrastimdrug

Given subcutaneously 24 hours after last chemotherapy dose