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Nab-paclitaxel, Cisplatin, Cetuximab and RT for Advanced Head and Neck Cancer
NCT00851877Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2009
- Primary completion
- Oct 2013
- Countries
- 1
- Sponsor
- UT Southwestern Medical Center
- Modality
- Polymer-based Nanoparticles, Small Molecules
- Drugs
- nab-paclitaxel
- Conditions
- head and neck squamous cell carcinoma (HNSCC)
01
Overview
Phase 2, open-label, single-arm trial of nab-paclitaxel in head and neck squamous cell carcinoma (HNSCC), sponsored by UT Southwestern Medical Center. Primary endpoints: Maximum Tolerated Dose of Nab-Paclitaxel at 90 days and Disease-free Survival at 2 years. Started Mar 2009; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Experimental Arm
Abraxane + Cisplatin + Cetuximab + IMRT
03
Endpoints
Primary
Maximum Tolerated Dose of Nab-Paclitaxel
Disease-free Survival
Secondary
Local Control
Overall Survival
Progression-free Survival
Response Rates
Dose-limiting Toxicities and Safety
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