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