Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06997068

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

Led by Mayo Clinic · Updated on 2026-05-11

25

Participants Needed

1

Research Sites

155 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histologically confirmed relapsed or metastatic head and neck cancer including oral cavity, oropharynx (HPV positive or negative), hypopharynx, and larynx
  • Measurable or non-measurable disease allowed
  • Prior treatment with first-line immunotherapy or chemo-immunotherapy or unable/refuse first-line therapy
  • ECOG Performance Status of 0, 1, or 2
  • Hemoglobin level of at least 9.0 g/dL within 15 days prior to registration
  • Absolute neutrophil count of at least 1500/mm3 within 15 days prior to registration
  • Platelet count of at least 100,000/mm3 within 15 days prior to registration
  • Total bilirubin less than or equal to 1.5 times the upper limit of normal within 15 days prior to registration
  • ALT and AST levels less than or equal to 3 times upper limit normal (or 5 times if liver involved) within 15 days prior to registration
  • PT/INR/aPTT less than or equal to 1.5 times upper limit normal or within target range if on anticoagulants within 15 days prior to registration
  • Creatinine clearance of at least 45 ml/min by CKD-EPI equation within 15 days prior to registration
  • Negative pregnancy test within 8 days prior to registration for persons of childbearing potential
  • Provide written informed consent
  • Ability to complete questionnaires alone or with assistance
  • Ability to swallow pills
  • Willing and able to adhere to study schedule including treatment and visits
Not Eligible

You will not qualify if you...

  • Pregnant or nursing persons
  • Persons of childbearing potential or able to father a child unwilling to use adequate contraception
  • Uncontrolled illnesses including recent myocardial infarction (within 6 months), advanced heart failure (NYHA class III or IV), prolonged QTc interval, uncontrolled arrhythmias, or poorly controlled angina
  • History of serious ventricular arrhythmia or conditions predisposing to arrhythmia
  • Active infection requiring systemic treatment
  • Active gastrointestinal bleeding
  • Psychiatric or social conditions limiting study compliance
  • Immunocompromised patients or HIV positive receiving antiretroviral therapy
  • Known hepatitis B or C infection unless controlled or cured as specified
  • Receiving other investigational agents for the primary cancer
  • Other active cancers requiring therapy except stable treated breast or prostate cancer or secondary malignancies with life expectancy at least 2 years
  • Severe concurrent diseases or systemic illnesses that interfere with safety or assessment as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

C

Clinical Trials Referral Office

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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