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Nab-Paclitaxel, Cisplatin, and Cetuximab With Concurrent Radiation Therapy for Locally Advanced Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:
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

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Paclitaxel albumin-stabilized nanoparticle formulation may make tumor cells more sensitive to radiation therapy. Giving radiation therapy and paclitaxel albumin-stabilized nanoparticle formulation together with cisplatin and cetuximab may kill more tumor cells.

PURPOSE: This phase I/II trial is studying the side effects and best dose of paclitaxel albumin-stabilized nanoparticle formulation when given together with cisplatin, cetuximab, and radiation therapy to see how well they work in treating patients with locally advanced stage III or stage IV head and neck cancer.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00851877
Study type Interventional
Source University of Texas Southwestern Medical Center
Contact
Status Completed
Phase Phase 1/Phase 2
Start date March 1, 2009
Completion date August 3, 2015
View Details
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