CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 54 enrolled
Drug / intervention
single arm dose dense MVACdrug
Likely dose
Not stated in 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/NCT01031420
NCT01031420Phase 2Completed

Phase II Trial of Neoadjuvant Dose Dense MVAC in Muscle Invasive Bladder Cancer and High Risk Urothelial Carcinoma of the Upper Urinary Tract

Fox Chase Cancer Center·interventional·Posted Dec 14, 2009·Updated Sep 17, 2019

In Brief

A Phase 2 clinical trial evaluating single arm dose dense MVAC for Muscle Invasive Bladder Cancer and High Risk Urothelial Carcinoma of the Upper Urinary Tracts. Completed, enrolled 54 participants across 2 sites.

Detailed Summary

Standard treatment for early stage bladder cancer is chemotherapy with methotrexate (M), vinblastine (V), adriamycin (A), and cisplatin (C) followed by surgical removal of any remaining cancer and the bladder with the intent of cure. The M V chemotherapy is usually given every 14 days with the AC given along each 28 days. This study looks at giving the same drugs at the same doses closer together, all drugs every 14 days, with the support of growth factor medication to promote growth of the white blood cells and platelets and allow chemotherapy to be finished sooner and surgery to be done sooner.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 14, 2009
Enrollment StartDec 7, 2009
Primary CompletionJul 19, 2013
Study CompletionAug 7, 2013
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 16.6 years ago

Interventions

single arm dose dense MVACdrug

standard doses of methotrexate, vinblastine, adriamycin, and cisplatin given every 14 days.