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Phase I Study of Weekly Nanoparticle Albumin-Bound Paclitaxel with Cetuximab and Intensity-Modulated Radiation Therapy in Patients with Locally Advanced Head and Neck Cancer

[Protocol 08-084]


Full Title :
PHASE I STUDY OF WEEKLY NANOPARTICLE ALBUMIN-BOUND PACLITAXEL (ABRAXANE) + WEEKLY CETUXIMAB + RADIATION THERAPY (IMRT, INTENSITY-MODULATED RADIATION THERAPY) IN PATIENTS WITH STAGE III-IVB HEAD AND NECK SQUAMOUS CELL CARCINOMA (HNSCC)
Purpose :

For patients with locally advanced head and neck squamous cell carcinoma that has not spread to other parts of the body, one standard treatment option is cetuximab plus radiation therapy. In this study, researchers wish to evaluate the addition of albumin-bound paclitaxel to the standard regimen of cetuximab plus radiation therapy. Albumin-bound paclitaxel is approved for the treatment of metastatic breast cancer; it is more effective than conventional paclitaxel for that disease.

Previous studies have shown that albumin-bound paclitaxel can kill head and neck cancer cells when given alone or in combination with chemotherapy. The purpose of this study is to establish a safe dose range of albumin-bound paclitaxel given in combination with cetuximab and intensity-modulated radiation therapy in patients with locally advanced head and neck cancer that has not yet been treated with chemotherapy or radiation therapy.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have stage III or IVB squamous cell carcinoma of the head and neck that has not yet been treated with chemotherapy or radiation therapy.

For more information and to inquire about eligibility for this study, please contact Dr. Matthew G. Fury at 212-639-3049.

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