5-Fluorouracil Response and Optimization Study (The FROST Trial)

Sponsor: Washington University School of Medicine

Sponsor score: 40

ClinicalTrials ID:NCT07419464

Provider View

This study is testing two different schedules of the chemotherapy drug 5-FU to see which is more effective and safer for patients with recurrent or metastatic head and neck cancer who have already tried other treatments.

Patient Parameters

Program Overview

The FROST Trial is a phase II study that aims to evaluate the effectiveness and safety of two different schedules of the chemotherapy drug 5-Fluorouracil (5-FU) for patients with recurrent or metastatic head and neck squamous cell carcinoma (RM-HNSCC). Patients in this study will have previously received treatments with platinum-based chemotherapy and PD-1 inhibitors. The study will compare two groups: one receiving 5-FU every two weeks and the other every three weeks. Researchers hope to see if either schedule can achieve a response rate of 10% or more, as well as monitor any side effects and treatment adjustments.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with specific types of head and neck cancer, including those in the oral cavity, throat, or voice box, or certain HPV-related cancers.
  • Cancer must be measurable by standard criteria.
  • Previously treated with platinum-based chemotherapy and PD-1 inhibitors, with cancer returning or progressing after these treatments.
  • At least 18 years old.
  • In good general health, with a performance status score of 2 or less.
  • Adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1.0 K/cumm.
    • Platelet count of at least 100 K/cumm.
    • Hemoglobin level of at least 8.0 g/dL.
    • Liver and kidney function within specified limits.
  • Women and men must agree to use effective contraception during the study and for 30 days after the last dose of 5-FU.
  • Recovery from previous treatment side effects to baseline or mild levels, unless they are stable and not significant.
  • Ability to understand and sign a consent form, or have a representative do so on their behalf.

Exclusion Criteria

  • Previously treated with 5-FU for RM-HNSCC.
  • Have another cancer that could interfere with the study.
  • Currently taking other experimental drugs.
  • Have certain types of head and neck cancer not included in the study.
  • Have a genetic deficiency affecting 5-FU metabolism.
  • Severe liver problems or history of hepatitis B or C.
  • Untreated brain metastases, unless treated and stable.
  • Allergic to 5-FU or similar drugs.
  • Pregnant or breastfeeding women.
  • HIV-positive patients not on effective treatment with undetectable viral load for 6 months.

Locations

FACILITYZIPCITYSTATE
Washington University School of Medicine63110St LouisMissouri

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