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

NCT06997068 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: MC24070124-009083
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head and Neck Cancer; Hypopharynx Cancer; Oropharynx Cancer; Recurrent Oral Cavity Carcinoma; Stage IVC Lip and Oral Cavity Cancer AJCC v8; Metastatic Oral Cavity Carcinoma; Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Metastatic Hypopharyngeal Carcinoma; Metastatic Laryngeal Carcinoma; Metastatic Malignant Head and Neck Neoplasm; Metastatic Oropharyngeal Carcinoma; Recurrent Hypopharyngeal Carcinoma; Recurrent Laryngeal Carcinoma; Recurrent Malignant Head and Neck Neoplasm; Recurrent Oropharyngeal Carcinoma; Stage IVC Hypopharyngeal Carcinoma AJCC v8; Stage IVC Laryngeal Cancer AJCC v8; Stage IVC Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Outcome Measures

Primary Outcomes (3)

• Rates of provider referral and patient enrollment (Feasibility)

  Will capture the provider/patient reasons for declining trial participation. All information will be described descriptively. Categorical variables will be described with frequencies and percentages. Continuous variables will be described with means, medians, standard deviations, etc.

  Up to 2 years

• Rate of retention (Feasibility)

  Will capture the reasons for trial drop-out and assess adherence to treatment and reasons for deviation through qualitative and semiquantitative means. All information will be described descriptively. Categorical variables will be described with frequencies and percentages. Continuous variables will be described with means, medians, standard deviations, etc.

  Up to 2 years

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

  Will capture the provider/patient reasons for the switch and quantify the out-of-pocket costs of in-person and virtual visits. All the information will be described descriptively. Categorical variables will be described with frequencies and percentages. Continuous variables will be described with means, medians, standard deviations, etc.

  Up to 2 years

Secondary Outcomes (4)

• Incidence of adverse events

  Up to 30 days after completion of study treatment

• Objective response rate

  Up to 3 years

• Progression-free survival

  Up to 3 years

• Overall survival

  Up to 3 years

Study Arms (1)

Treatment (methotrexate, erlotinib, celecoxib)

EXPERIMENTAL

Patients receive methotrexate PO on days 1, 8, 15, and 22 of each cycle, erlotinib PO QD on days 1-28 of each cycle, and celecoxib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SOC imaging scans throughout the trial.

Drug: Celecoxib; Drug: Erlotinib Hydrochloride; Procedure: Imaging Procedure; Other: Interview; Drug: Methotrexate; Other: Questionnaire Administration

Interventions

Erlotinib Hydrochloride DRUG

Given PO

Also known as: CP 358, CP-358, Cp-358,774, CP358, OSI 774, OSI-774, OSI774, Tarceva

Treatment (methotrexate, erlotinib, celecoxib)

Celecoxib DRUG

Given PO

Also known as: Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-, Celebrex, Elyxyb, Onsenal, SC-58635, YM 177

Treatment (methotrexate, erlotinib, celecoxib)

Imaging Procedure PROCEDURE

Undergo SOC imaging scans

Also known as: Diagnostic Imaging Technique, Image Type, Imaging, Imaging (procedure), Imaging Procedures, Imaging Technique, imaging type, IMAGING_METHOD, imaging_type, Medical Imaging, Type of imaging

Treatment (methotrexate, erlotinib, celecoxib)

Interview OTHER

Ancillary studies

Treatment (methotrexate, erlotinib, celecoxib)

Methotrexate DRUG

Given PO

Also known as: Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate, CL 14377, CL-14377, Emtexate, Emthexat, Emthexate, Farmitrexat, Fauldexato, Folex, Folex PFS, Jylamvo, Lantarel, Ledertrexate, Lumexon, Maxtrex, Medsatrexate, Metex, Methoblastin, Methotrexate LPF, Methotrexate Methylaminopterin, Methotrexatum, Metotrexato, Metrotex, Mexate, Mexate-AQ, MTX, Novatrex, Rheumatrex, Texate, Tremetex, Trexeron, Trixilem, WR-19039

Treatment (methotrexate, erlotinib, celecoxib)

Questionnaire Administration OTHER

Ancillary studies

Treatment (methotrexate, erlotinib, celecoxib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Histologically confirmed diagnosis of relapsed/metastatic head and neck cancer, including oral cavity, oropharynx \[human papillomavirus (HPV) 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)

You may not qualify if:

• Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown
• Pregnant persons
• Nursing persons
• Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception
• Uncontrolled intercurrent illness including, but not limited to:
• Myocardial infarction ≤ 6 months prior to registration
• New York Heart Association (NYHA) class III or IV heart failure
• Corrected QT interval (QTc) prolongation more than 440 ms in males and 460 ms in females
• Uncontrolled dysrhythmias or poorly controlled angina
• History of serious ventricular arrhythmia \[ventricular tachycardia (VT) or ventricular flutter (VF)\] and/or factors that predispose to arrhythmia (e.g., heart failure, hypokalemia, family history of long QT syndrome)
• Ongoing or active infection requiring systemic treatment
• Active gastrointestinal bleeding
• Psychiatric illness/social situations that would limit compliance with study requirements
• Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy
• NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Mouth Neoplasms; Head and Neck Neoplasms; Hypopharyngeal Neoplasms; Oropharyngeal Neoplasms; Laryngeal Neoplasms; Carcinoma

Interventions

Celecoxib; Erlotinib Hydrochloride; X-Rays; Interviews as Topic; Methotrexate; merphos

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Aminopterin; Pterins; Pteridines

Study Officials

• Katharine A. Price, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: July 9, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

US (1)