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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Celecoxib
  • Erlotinib Hydrochloride
  • Imaging Procedure
  • Interview
  • Methotrexate
  • Questionnaire Administration

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators