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Paclitaxel Plus Gemcitabine in Advanced Urothelial Carcinoma With Renal Insufficiency
NCT00005644Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2001
- Primary completion
- Feb 2003
- Countries
- 1
- Sponsor
- Eastern Cooperative Oncology Group
- Modality
- Small Molecules
- Conditions
- urothelial carcinoma (UC)
01
Overview
Phase 2, open-label, single-arm trial of paclitaxel and gemcitabine in urothelial carcinoma (UC), sponsored by Eastern Cooperative Oncology Group. Primary endpoints: Objective Response Rate up to 5 years and Toxicity up to 5 years. Started Jan 2001; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Paclitaxel + Gemcitabine
Paclitaxel and gemcitabine combination therapy
03
Who it enrols
Adult patients with progressive regional or metastatic transitional cell carcinoma of the urothelium and renal insufficiency (GFR <= 50 mL/min), with no prior chemotherapy for advanced disease.
04
Endpoints
Primary
Objective Response Rate
Toxicity
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