NCT03769311

Cetuximab in Head and Neck Cancer Patients

A Window of Opportunity Trial of Cetuximab in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial is for participants with head and neck squamous cell carcinoma who are scheduled to have their tumor surgically removed. The study involves obtaining baseline tissue from a clinical biopsy or research biopsy and measurement of circulating tumor cells before surgery to determine whether AXL protein expression pre-treatment correlates to clinical outcomes (change in tumor size) after two doses of cetuximab. The importance of this study is to describe if AXL expression can be used as a biomarker to predict clinical response to cetuximab (CTX) treatment.

Detailed 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 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: 1. To correlate AXL expression with change in Ki67 following cetuximab in Head and Neck Cancer (HNC) patients 2. To examine other putative markers of cetuximab sensitivity such as HER3 and change in circulating tumor cells 3. 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.

Conditions

• Head and Neck Cancer
• Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Cetuximab	Monoclonal antibody against epidermal growth factor receptor (EGFR)

Timeline

• Start date: 2019-04-17
• Primary completion: 2022-03-15
• Completion: 2022-03-15
• First posted: 2018-12-07
• Last updated: 2023-05-24
• Results posted: 2023-05-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study