Trial intelligence / Profile preview

Pemetrexed and Gemcitabine in Advanced Urothelial Cancer

NCT00053209Phase 2

Key facts

Status
Completed
Start
Aug 2004
Primary completion
Sep 2007
Countries
1
Sponsor
Eastern Cooperative Oncology Group
Modality
Small Molecules
Conditions
urothelial carcinoma (UC)
01

Overview

Phase 2, open-label, single-arm trial of pemetrexed in urothelial carcinoma (UC), sponsored by Eastern Cooperative Oncology Group. Primary endpoints: Objective Response Rate and Toxicity. Started Aug 2004; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • Pemetrexed + Gemcitabine

    Pemetrexed disodium and gemcitabine combination chemotherapy

03

Who it enrols

Patients with histologically confirmed advanced urothelial cancer (TCC or mixed) who have not received prior systemic chemotherapy for metastatic disease. Must have adequate organ function and ECOG PS 0-2.

04

Endpoints

Primary

  • Objective Response Rate

  • Toxicity

Secondary

  • Time to Progression

  • Overall Survival

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