Washington University School of Medicine
This randomized phase II trial will characterize the efficacy, adverse event (AE) profile, and safety of two regimens of 5-FU given as 2L+ treatment to patients with RM-HNSCC. Eligible patients for this trial will have previously received platinum and PD-1 inhibitor therapy. The experimental regimen (Arm 1) will comprise the two days every two weeks (2D-Q2W) regimen of 5-FU. The standard regimen (Arm 2) will consist of the four days every three weeks (4D-Q3W) regimen of 5-FU. The primary hypotheses is that each regimen of 5-FU will result in an ORR of 10% of greater assessed by RECIST v1.1 criteria. The study will also describe treatment-related AEs assessed by CTCAE v5.0, dose interruptions, discontinuations, and modifications in each regimen.
Inclusion Criteria: * Histologically or cytologically confirmed: * RM-HNSCC of the oral cavity, oropharynx, larynx, or hypopharynx, OR * p16+ (HPV-related) level 2-3 neck node and unknown primary site, OR * Second primary HNSCC in a previously radiated field not amenable to curative-intent surgery and/or re-radiation. * Measurable disease per RECIST 1.1. * Previously treated with platinum-based chemotherapy, RM disease within 6 months of definitive cisplatin + radiation therapy (DCisRT) or post-operative adjuvant cisplatin + radiation therapy (POACisRT) OR progressive disease on or aft…
Dose modifications or reductions are determined by patient's tolerability to the drug.