Trial intelligence / Profile preview

Neoadjuvant ABI-007, Carboplatin and Gemcitabine in Locally Advanced Bladder Cancer

NCT00585689Phase 2

Key facts

Status
Completed
Start
Dec 2007
Primary completion
Apr 2013
Countries
1
Sponsor
University of Michigan Rogel Cancer Center
Modality
Polymer-based Nanoparticles, Small Molecules
Conditions
bladder cancer
01

Overview

Phase 2, open-label, single-arm trial of nab-paclitaxel in bladder cancer, sponsored by University of Michigan Rogel Cancer Center. Primary endpoint: Complete Pathologic Response at 63 days. Started Dec 2007; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Neoadjuvant ABI-007, Carboplatin, and Gemcitabine

    Experimental arm receiving 3 cycles of neoadjuvant ABI-007, carboplatin, and gemcitabine prior to radical cystectomy.

03

Who it enrols

Patients with locally advanced urothelial carcinoma of the bladder who are candidates for cystectomy, have adequate organ function, ECOG PS 0-2, and no prior systemic chemotherapy or radiotherapy.

04

Endpoints

Primary

  • Complete Pathologic Response

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