This phase II trial compares two dosing schedules of fluorouracil (5-FU): 1) As an intravenous (IV) bolus followed by continuous IV infusion for 2 days-once every two weeks (2D-Q2W), and 2) As a continuous IV infusion over 4 days-once every four weeks (4D-Q3W), for treating patients that have previously received a platinum agent and PD-1 inhibitor for head and neck cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Typical treatment for patients that have received a platinum agent and PD-1 inhibitor for recurrent or metastatic head and neck cancer is 5-FU. Chemotherapy drugs, such as 5-FU, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. The two common ways to give 5-FU include either the 2D-Q2W or 4D-Q3W schedule; however, there is a need to look more at the side effects and how well these schedules work. Researchers hope that by comparing the 2D-Q2W and 4D-Q3W 5-FU schedules they will be able to determine which is the safer, more tolerable, and/or more effective schedule in treating patients that have previously received a platinum agent and PD-1 inhibitor for recurrent or metastatic head and neck cancer.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07419464.
Locations matching your search criteria
United States
Missouri
Saint Louis
Siteman Cancer Center at Washington UniversityStatus: Active
Contact: Christine Auberle
Phone: 314-747-1459
PRIMARY OBJECTIVE:
I. To determine the overall response rate (ORR) by arm of patients with recurrent or metastatic (RM)-head and neck squamous cell carcinoma (HNSCC) receiving the 2D-Q2W regimen of 5-FU or the 4D-Q3W regimen of 5-FU.
SECONDARY OBJECTIVES:
I. To determine the rate of patients requiring a dose reduction due to treatment related adverse event (TRAE) for each arm.
II. To determine the rate of patients requiring a dose interruption or delay due to TRAE for each arm.
III. To determine the rate of patients requiring treatment discontinuation due to TRAE for each arm.
IV. To evaluate the daily dose intensity for each arm.
V. To determine the frequency of adverse events (AEs) by grade (3, 4, and 5) and type for each arm.
VI. To determine the frequency of adverse events of specific interest (AESI): diarrhea, mucositis, palmar- plantar erythrodysesthesia (hand-foot syndrome) (PPE/HFS), neutropenia, and thrombocytopenia by grade (1-5, 1-2, 3, 4, and 5) for each arm.
VII. To evaluate the frequency of treatment-related deaths in each arm.
VIII. To determine the duration of response (DoR) in each arm.
IX. To determine the progression-free survival (PFS) in each arm.
X. To determine the overall survival (OS) in each arm.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Patients receive 5-FU IV bolus followed by continuous IV infusion over 46 hours on days 1-2 and 15-16 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
ARM 2: Patients receive 5-FU continuous IV infusion on days 1-4 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Additionally, all patients undergo computed tomography (CT) throughout the study.
After completion of study treatment, patients are followed up at 28 days and then every 3 months for up to 3 years.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorChristine Auberle
