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Brief Title: Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Official Title: A Phase II Study of Carboplatin, Nab-paclitaxel and Cetuximab for Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Study ID: NCT01412229
Brief Summary: This is a non-randomized, open-label phase II trial of 40 patients with poor prognosis head and neck cancer, defined as surgically unresectable and/or ≥N2b disease and judged appropriate for non-surgical definitive therapy.
Detailed Description: This is a non-randomized, open-label phase II trial of 40 patients with poor prognosis head and neck cancer, defined as surgically unresectable and/or ≥N2b disease and judged appropriate for non-surgical definitive therapy. Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 with good organ function and will be treated with six weekly cycles of carboplatin, nab-paclitaxel and cetuximab prior to scheduled concomitant chemoradiation. The study is designed to evaluate whether this induction regimen can result in an improved response rate (complete response (CR) + partial response (PR)) with less toxicity than the current standard induction docetaxel, cisplatin and 5-fluorouracil (TPF) regimen.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Vanderbilt University, Nashville, Tennessee, United States
University of Washington, Seattle, Washington, United States
Name: Jared Weiss, MD
Affiliation: University of North Carolina, Chapel Hill
Role: PRINCIPAL_INVESTIGATOR