RecruitingPhase 2

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

United States25 participantsStarted 2025-07-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 18 years * Histologically confirmed diagnosis of relapsed/metastatic head and neck cancer, including oral cavity, oropharynx (NPV positive and negative), hypopharynx, and larynx cancer * Measurable or non-measurable disease is allowed * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria * Non-measurable disease * NOTE: Other nonmeasurable lesions include clinically evident lesions not well visualized on imaging \[e.g., oral cavity mass readily seen on physical exam but obscured on computed tomography (CT)\], dermal metastases, and bone metastases * Prior treatment: * One of the following must be true: * Received standard 1st-line immunotherapy or chemo-immunotherapy OR * Unable to receive or refuse 1st-line therapy * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2 * Hemoglobin ≥ 9.0 g/dL (obtained 15 days prior to registration) * Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained 15 days prior to registration) * Platelet count ≥ 100,000/mm\^3 (obtained 15 days prior to registration) * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained 15 days prior to registration) * Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained 15 days prior to registration) * Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) ≤ 1.5 x …

What they're measuring

Rates of provider referral and patient enrollment (Feasibility)

Timeframe: Up to 2 years

Rate of retention (Feasibility)

Timeframe: Up to 2 years

Rate of conversion from virtual to in-person visits (Feasibility)

Timeframe: Up to 2 years

Trial details

NCT IDNCT06997068

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-06-30

Contact for this trial

Clinical Trials Referral Office

855-776-0015 mayocliniccancerstudies@mayo.edu

View on ClinicalTrials.gov More Metastatic Oral Cavity Carcinoma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.