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.
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.
Prior 5-FU given to treat RM-HNSCC.
Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.
Currently receiving any other investigational agents.
RM or incurable second primary SCC of cutaneous, nasopharynx, paranasal/nasal/sinus origin.
Parallel
5-Fluorouracil
DrugDose modifications or reductions are determined by patient's tolerability to the drug.
Overall response rate (ORR)
* ORR, defined as CR and PR per RECIST v1.1. * Complete Response (CR): Disappearance of all target lesions. Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). * Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Incidence of patients requiring a dose reduction due to treatment related adverse events (TRAEs)
Incidence of patients requiring a dose interruption or delay due to treatment related adverse events (TRAEs)
Incidence of patients requiring treatment discontinuation due to treatment related adverse events (TRAEs)
Daily dose intensity
Daily dose intensity will be measured as the average daily dose/m2 of 5-FU administered in the treatment interval for each regimen (Days 1-2 and Days 15-16 for Arm 1 and Days 1-4 for Arm 2).
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Washington University School of Medicine
Lead sponsor
The Joseph Sanchez Foundation
Collaborator
