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Study of Methotrexate, Erlotinib, and Celecoxib for Recurrent/Metastatic Head and Neck Cancer

This study is looking at the safety and effectiveness of combining three medicines: methotrexate, erlotinib, and celecoxib, for people in the rural Midwest who have head and neck cancer that has come back (recurrent) or spread (metastatic). Methotrexate works by stopping cancer cells from using a substance they need to grow. Erlotinib is a kinase inhibitor, meaning it blocks a protein (EGFR) that helps cancer cells multiply. Celecoxib is also given. The study aims to see how many people join and stay in the study, and how often virtual visits are used. You may be able to join if you are 18 or older and have a confirmed diagnosis of recurrent or metastatic head and neck cancer. The study plans to enroll 25 participants, but its current status is unclear.

Study design
This is an interventional study with a planned enrollment of 25 participants. It is a Phase II trial, meaning it gathers information on feasibility, safety, and effect.
What's involved
Participants will receive celecoxib, erlotinib, and methotrexate by mouth. They will also undergo standard-of-care imaging scans and participate in interviews for ancillary studies.
Compensation
Not stated in the trial record.
Follow-up
The study measures feasibility endpoints, such as enrollment and retention rates, for up to 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06997068

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Mayo Clinic
~25 participants
Updated 2026-05-11 on ClinicalTrials.gov
What's tested:CelecoxibErlotinib HydrochlorideImaging ProcedureInterviewMethotrexateQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rates of provider referral and patient enrollment (Feasibility)
Measured over Up to 2 years
+2 more outcomes measured

Conditions

Metastatic Oral Cavity Carcinoma
Recurrent Oral Cavity Carcinoma
Stage IVC Lip and Oral Cavity Cancer AJCC v8
Head and Neck Cancer
Hypopharynx Cancer
Oropharynx Cancer
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

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Hypopharyngeal CarcinomaLaryngeal CarcinomaLip and Oral Cavity CarcinomaMalignant Head and Neck NeoplasmOral Cavity CarcinomaOropharyngeal CarcinomaSoluble Epidermal Growth Factor Receptor

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Katharine A. Price, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic in Rochester

Who to contact

Clinical Trials Referral Office
[email protected]
855-776-0015
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)
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 ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained 15 days prior to registration)
Calculated creatinine clearance ≥ 45 ml/min per Chronic-Kidney Disease-Epidemiology (CKD-EPI) Creatinine Equation (obtained 15 days prior to registration)
Estimated creatinine clearance (Clcr) by the CKD-EPI Creatinine Equation (per National Kidney Foundation) (obtained 15 days prior to registration)
Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only
Provide written informed consent
Ability to complete questionnaire(s) by themselves or with assistance
Ability to swallow pills
Willing and able to adhere with the protocol schedule for the duration of the study including undergoing treatment, attending scheduled visits, and examinations

Exclusion

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
Known hepatitis
Exception: For patients with evidence of chronic hepatitis B virus infection the hepatitis B (HepB) viral load must be undetectable on suppressive therapy, if indicated, to be eligible
Exception: Patients with a history of hepatitis C virus infection must have been treated and cured. Patients with hepatitis C virus (HCV) infection who are currently on treatment are eligible if they have an undetectable HCV viral load
Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
Other active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy. Patients on hormonal therapy for treated breast or prostate cancer are permitted if they meet other eligibility criteria
NOTE: Patients with secondary malignancy with life expectancy ≥ 2 years are eligible
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

What this trial measures

  • Rates of provider referral and patient enrollment (Feasibility)Up to 2 years

    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.

  • Rate of retention (Feasibility)Up to 2 years

    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.

  • Rate of conversion from virtual to in-person visits (Feasibility)Up to 2 years

    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.