Cetuximab in Head and Neck Cancer Patients

Summary

Participation Requirements

Description

This is a window of opportunity trial evaluating the hypothesis that AXL levels correlate with clinical response to cetuximab in head and neck patients. Patients with head and neck squamous cell carcinoma who are scheduled to undergo surgical resection of their tumor and are candidates for cetuximab...

This is a window of opportunity trial evaluating the hypothesis that AXL levels correlate with clinical response to cetuximab in head and neck patients. Patients with head and neck squamous cell carcinoma who are scheduled to undergo surgical resection of their tumor and are candidates for cetuximab chemotherapy are eligible to participate. Primary: 1. To test the hypothesis that low AXL correlates with clinical response to cetuximab in head and neck cancer patients Secondary: 1. To further describe the safety of pre-operative administration of cetuximab Correlative: To correlate AXL expression with change in Ki67 following cetuximab in Head and Neck Cancer (HNC) patients To examine other putative markers of cetuximab sensitivity such as HER3 and change in circulating tumor cells To establish the first panel of patient-derived xenografts from patients with known sensitivity or resistance to cetuximab Following informed consent, tumor tissue from the research biopsy and a blood draw for circulating tumor cells will be obtained. The participant will then receive two weekly doses of pre-operative cetuximab during the interval between diagnostic biopsy and surgery (~14 days), ensuring that no delay in standard of care (SOC) will occur. For dose #1, participants will receive cetuximab 400 mg/m2 via intravenous infusion over 2 hours (maximum infusion rate 10 mg/min) as per the standard of care loading regimen for cetuximab monotherapy. For dose #2, participants will receive cetuximab 250 mg/m2 via intravenous infusion over 1 hour (maximum infusion rate 10 mg/min) as per the standard of care dosing regimen for cetuximab monotherapy. At the time of surgery, another blood draw will be obtained for analysis of circulating tumor cells, and a portion of the resected tumor will be obtained for study analysis. Correlative studies will include the measurement of proteins hypothesized to be involved in cetuximab resistance such as AXL, Ki67, EGFR, and HER3 expression from both the biopsy and the surgical specimen. Blood will be analyzed for correlative analysis of circulating tumor cells. Tissue from the research biopsy will be utilized for participant-derived xenograft (PDX) development.

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