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Triple Oral Metronomic Chemotherapy in Recurrent/Metastatic Head and Neck Cancer
NCT06997068Phase 2
Key facts
- Status
- Recruiting
- Start
- Aug 2025
- Primary completion
- Aug 2029
- Countries
- 1
- Sponsor
- Mayo Clinic
- Modality
- Orthosteric Ligands
- Conditions
- head and neck cancer (HNC)
01
Overview
Phase 2, open-label, single-arm trial of methotrexate, erlotinib and celecoxib oral solution in head and neck cancer (HNC), sponsored by Mayo Clinic. Primary endpoints: Rates of provider referral and patient enrollment up to 2 years, Rate of retention up to 2 years and 1 more. Started Aug 2025; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Treatment (methotrexate, erlotinib, celecoxib)
Patients receive methotrexate, erlotinib, and celecoxib orally.
03
Who it enrols
Adults with recurrent/metastatic head and neck cancer who received or were unable to receive 1st-line immunotherapy/chemo-immunotherapy, with ECOG PS 0-2 and adequate organ function.
04
Endpoints
Primary
Rates of provider referral and patient enrollment
Rate of retention
Rate of conversion from virtual to in-person visits
Secondary
Incidence of adverse events
Objective response rate
Progression-free survival
Overall survival
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