At a glance
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A Phase II Trial of a Protease Inhibitor, Nelfinavir (NFV), Given With Definitive, Concurrent Chemoradiotherapy (CTRT) in Patients With Locally-Advanced, Human Papilloma Virus (HPV) Negative, Squamous Cell Carcinoma of the Head and Neck
In Brief
A Phase 2 clinical trial evaluating Nelfinavir (Viracept®) 1250 mg and Chemoradiation for Head and Neck Squamous Cell Carcinoma. Completed, enrolled 18 participants across 1 site.
Detailed Summary
This is a Phase II trial of definitive chemoradiotherapy (CTRT) given with the protease inhibitor,Nelfinavir (NFV), in patients with locally advanced head and neck. Eligible patients will receive a "lead-in" period of Nelfinavir (1250 mg po bid) for 7-14 days prior to initiation of CTRT. Nelfinavir will then be given concurrently with platinum-based chemotherapy and radiation therapy (planned total dose of 70 Gy over 7 weeks).
Study Details
Timeline
Interventions
Period 1: Nelfinavir Lead-In (1250 mg bid, 7-14 days).
Period 2: Concurrent Chemoradiation (70 Gy over 7 weeks) with Nelfinavir (1250 mg bid)