A Phase I/II Study of Nab-paclitaxel, Cisplatin and Cetuximab With Concurrent Radiation Therapy for Local-regionally Advanced Head-and-neck Squamous Cell Carcinoma
OBJECTIVES:
Primary
- To determine the maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle
formulation when combined with cisplatin, cetuximab, and radiotherapy in patients with
local-regionally advanced squamous cell carcinoma of the head and neck. (Phase I)
- To evaluate the disease-free survival of patients treated with this regimen. (Phase II)
Secondary
- To identify dose-limiting toxicities in these patients treated with this regimen.
(Phase I)
- To assess the safety and tolerability of this regimen. (Phases I and II)
- To assess progression-free survival and survival of patients treated with this regimen.
(Phase I)
- To assess overall survival in patients treated with this regimen. (Phase II)
- To assess response rates in patients treated with this regimen. (Phases I and II)
OUTLINE: This is a multicenter, phase I dose-escalation study of paclitaxel
albumin-stabilized nanoparticle formulation followed by a phase II study.
Patients receive cetuximab IV over 120 minutes in week 1. Patients then receive cetuximab IV
over 60 minutes, paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes,
and cisplatin IV over 60 minutes once weekly in weeks 2-8. Patients also undergo 3D
conformal or intensity-modulated radiotherapy over 30 minutes on days 1-5 in weeks 2-8.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 4 years.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation
Maximum tolerated dose of paclitaxel albumin-stabilized nanoparticle formulation
2 years
Yes
Hak Choy, MD
Principal Investigator
Simmons Cancer Center
United States: Food and Drug Administration
CDR0000634258
NCT00851877
March 2009
December 2018
Name | Location |
---|---|
University of Texas Southwestern Medical Center | Dallas, Texas |
Baylor Research Institute | Dallas, Texas 75246 |