Washington University School of Medicine
This is a phase II trial of aspirin and paclitaxel in patients with recurrent/metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) who have received prior platinum and PD-1 inhibitor treatment and have an alteration in the PI3K pathway.
Inclusion Criteria: * Recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). Eligible primary tumor sub-sites include oral cavity, oropharynx, larynx, hypopharynx, nasal cavity and paranasal sinus. Also allowed: * P16+ (HPV-related) level 2-3 neck node and unknown primary * Second primary HNSCC in a previously radiated field not amenable to curative-intent surgery and/or re-radiation * PI3K alteration (defined in protocol) or PIK3CA amplification * Measurable disease per RECIST 1.1. * Previously treated with platinum-based chemotherapy in one of the following ways: * R/M d…
Aspirin is administered orally at a 162 mg dose. Aspirin will be administered each day and taken at approximately the same time every day, with or without food.
Paclitaxel will be administered intravenously at a dose of 80 mg/m\^2.
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