CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
Gemcitabine and Cisplatin (DD GC)drug
Likely dose
Gemcitabine and Cisplatin (DD GC) 2,500 mg/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/NCT01589094
NCT01589094Phase 2Completed
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Phase II Study of Neoadjuvant Dose Dense Gemcitabine and Cisplatin (DD GC) In Patients With Muscle-Invasive Bladder Cancer

Memorial Sloan Kettering Cancer Center·interventional·Posted May 1, 2012·Updated Oct 2, 2019

In Brief

A Phase 2 clinical trial evaluating Gemcitabine and Cisplatin (DD GC) for Bladder Cancer. Completed, enrolled 51 participants across 8 sites.

Detailed Summary

The purpose of this study is to find out if standard chemotherapy (gemcitabine and cisplatin) given on a dose-dense treatment schedule (with less time between treatments) can help shrink the tumor better than standard chemotherapy given on a standard treatment schedule before the patient undergoes surgery for bladder cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBladder Cancer
CountriesUnited States
CollaboratorsUniversity of North Carolina, Chapel Hill, New York University

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 1, 2012
Enrollment StartApr 1, 2012
Primary CompletionAug 1, 2018
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 14.2 years ago

Interventions

Gemcitabine and Cisplatin (DD GC)drug

Patients will receive six cycles of GC administered every 14 days. Gemcitabine 2,500 mg/m2 will be administered intravenously on day 1 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 2 of a 14 days cycle (with Peg GCSF). A total of six cycles of therapy will be administered followed by radical cystectomy with bilateral pelvic lymph node dissection (PLND)