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Metastatic Oral Cavity CarcinomaPhase 2NCT06997068

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

A Phase 2 study testing Celecoxib, Erlotinib Hydrochloride and Imaging Procedure in people with Metastatic Oral Cavity Carcinoma and Recurrent Oral Cavity Carcinoma, run by Mayo Clinic at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Celecoxib, Erlotinib Hydrochloride and Imaging Procedure
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
7 Aug 2025to 5 Aug 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trials Referral Office contact

855-776-0015

mayocliniccancerstudies@mayo.edu

United States1 site, 1 recruiting

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Katharine A. Price, MD

    Recruiting

Other trials in United States

About this study

Official title: 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

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.

Being tested
Celecoxib, Erlotinib Hydrochloride, Imaging Procedure, Interview, Methotrexate
Medical subject headings
Mouth Neoplasms, Head and Neck Neoplasms, Hypopharyngeal Neoplasms, Oropharyngeal Neoplasms, Laryngeal Neoplasms, Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CelecoxibDrug

    Also called Benzenesulfonamide, 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]-, Celebrex, Elyxyb, Onsenal

    Given PO

  • Erlotinib HydrochlorideDrug

    Also called CP 358, CP-358, Cp-358,774, CP358

    Given PO

  • Imaging ProcedureProcedure or surgery

    Also called Diagnostic Imaging Technique, Image Type, Imaging, Imaging (procedure)

    Undergo SOC imaging scans

  • InterviewOther

    Ancillary studies

  • MethotrexateDrug

    Also called Abitrexate, Alpha-Methopterin, Amethopterin, Brimexate

    Given PO

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT06997068
Study groupRoleWhat they receive
Treatment (methotrexate, erlotinib, celecoxib)ExperimentalPatients 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.
Receives: Drug: Celecoxib; Drug: Erlotinib Hydrochloride; Procedure: Imaging Procedure; Other: Interview; Drug: Methotrexate; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 2 years

  2. 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.

    Measured: Up to 2 years

  3. 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.

    Measured: Up to 2 years

Secondary outcomes (4)

  1. Incidence of adverse events

    The maximum grade for each type of adverse event will be recorded for each patient, assessed per Common Terminology Criteria in Adverse Events (CTCAE) version 5.0.

    Measured: Up to 30 days after completion of study treatment

  2. Objective response rate

    Defined as the proportion of participants who have a partial response or complete response, as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Measured: Up to 3 years

  3. Progression-free survival

    Defined as the time from study entry until the first of either disease progression or death from any cause.

    Measured: Up to 3 years

  4. Overall survival

    Defined as the time from study entry until death from any cause.

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2025
  2. Study start7 Aug 2025
  3. Primary completion5 Aug 2029 (estimated)
  4. Study completion5 Aug 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06997068
Sponsor's protocol ID
MC240701
Other IDs
24-009083
Status last verified
Sep 2026
First submitted
21 May 2025
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Celecoxib, Erlotinib Hydrochloride and Imaging Procedure in people with Metastatic Oral Cavity Carcinoma and Recurrent Oral Cavity Carcinoma, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rates of provider referral and patient enrollment (Feasibility) (time frame: Up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06997068.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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