RecruitingPhase 2NCT06997068

Methotrexate, Erlotinib, and Celecoxib for the Treatment of Recurrent/Metastatic Head and Neck Cancer in a Rural Midwest United States Population

MC240701 Decentralized Pilot Study of Triple Oral Metronomic Chemotherapy for Patients With Recurrent/Metastatic Head and Neck Cancer in a Rural Midwest United States Population


Sponsor

Mayo Clinic

Enrollment

25 participants

Start Date

Jul 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This phase II trial gathers information on the feasibility, safety, and effect of giving methotrexate, erlotinib, and celecoxib in treating 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) among rural Midwest patients. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid and may kill tumor cells. Erlotinib is in a class of medications called kinase inhibitors. It works by blocking the action of a protein called EGFR that signals tumor cells to multiply. This helps slow or stop the spread of tumor cells. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving the combination of methotrexate, erlotinib, and celecoxib may be feasible, safe, and effective in treating rural Midwest patients with recurrent/metastatic head and neck cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of three drugs — methotrexate, erlotinib, and celecoxib — in people with relapsed or metastatic oral cavity cancer (cancer in the mouth) who have already received first-line treatment. This is aimed at patients in rural areas of the Midwest United States who have limited access to standard clinical trials. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of relapsed or metastatic oral cavity cancer - You have already received or are unable to receive first-line immunotherapy or chemo-immunotherapy - Your blood counts, liver, and kidney function are adequate - You can swallow pills **You may NOT be eligible if...** - You are pregnant, breastfeeding, or not willing to use contraception - You have uncontrolled heart disease (e.g., recent heart attack, severe heart failure, abnormal heart rhythm) - You have active hepatitis B or C (with detectable viral load) - You have another active cancer requiring treatment - You have psychiatric conditions that would prevent study compliance Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCelecoxib

Given PO

DRUGErlotinib Hydrochloride

Given PO

PROCEDUREImaging Procedure

Undergo SOC imaging scans

OTHERInterview

Ancillary studies

DRUGMethotrexate

Given PO

OTHERQuestionnaire Administration

Ancillary studies


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT06997068


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