At a glance
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An Exploratory Study to Assess the Modulation of Biomarkers in Patients With Squamous Cell Carcinomas of the Head and Neck Randomized to Receive Preoperative Treatment With Cetuximab and/or IMC-A12, an Anti-insulin-like Growth Factor-1 Receptor Monoclonal Antibody
In Brief
A Phase 2 clinical trial evaluating Cetuximab, IMC-A12, and 1 other intervention for Head and Neck Squamous Cell Carcinoma. Completed, enrolled 16 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to give cetuximab and/or IMC-A12 before surgery for squamous cell carcinoma of the head and neck, in order to learn if these study drugs may cause changes in biomarkers. Biomarkers are chemical "markers" in the blood and/or tissue that may be related to a reaction to study treatment. The safety of the study treatments will also be studied.
Study Details
Timeline
Interventions
First dose of 400 mg/m\^2 by vein on Days 1 and 8 over 2 hours, second dose of 250 mg/m\^2 on week 2 and 3 (if applicable) given over 1 hour.
6 mg/kg/week by vein on Days 1 and 8 over 1 hour on weeks 1 and 2 and 3 (if applicable).
Surgical tumor resection on Day 10.