CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
Docetaxel +1 moredrug
Likely dose
Docetaxel 75 mgfrom 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/NCT03159143
NCT03159143Phase 2Completed

A Phase II, Single-arm Study of Docetaxel and Oxaliplatin in Metastatic Cisplatin-resistant Transitional Cell Carcinoma of the Urinary Bladder

Leonard Appleman·interventional·Posted May 18, 2017·Updated Aug 11, 2017

In Brief

A Phase 2 clinical trial evaluating Docetaxel and Oxaliplatin for Metastatic Transitional Cell Cancer of the Urothelial Tract. Completed, enrolled 22 participants across 1 site.

Detailed Summary

The purpose of this non-randomized Phase II trial was to evaluate the efficacy of a combination of docetaxel and oxaliplatin in patients with metastatic transitional cell cancer (TCC) of the urothelial tract. The primary endpoint was to assess response, as defined as a 25% reduction in measurable disease per the RECIST criteria. Measurable or evaluable objective response rate, time to disease progression and survival were also assessed.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsSanofi-Synthelabo

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 18, 2017
Enrollment StartDec 17, 2004
Primary CompletionJun 2, 2009
Study CompletionDec 2, 2009
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 9.1 years ago

Interventions

Docetaxeldrug

Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m\^2.

Oxaliplatindrug

Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m\^2