Health TrialsbyHealthPanel

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

ConditionsMetastatic Oral Cavity CarcinomaRecurrent Oral Cavity CarcinomaStage IVC Lip and Oral Cavity Cancer AJCC v8Head and Neck CancerHypopharynx CancerOropharynx CancerClinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8Metastatic Hypopharyngeal CarcinomaMetastatic Laryngeal CarcinomaMetastatic Malignant Head and Neck NeoplasmMetastatic Oropharyngeal CarcinomaRecurrent Hypopharyngeal CarcinomaRecurrent Laryngeal CarcinomaRecurrent Malignant Head and Neck NeoplasmRecurrent Oropharyngeal CarcinomaStage IVC Hypopharyngeal Carcinoma AJCC v8Stage IVC Laryngeal Cancer AJCC v8Stage IVC Oropharyngeal (p16-Negative) Carcinoma AJCC v8
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Celecoxib

    Drug

    Given PO

  • Erlotinib Hydrochloride

    Drug

    Given PO

  • Imaging Procedure

    Procedure/Surgery

    Undergo SOC imaging scans

  • Interview

    Other intervention

    Ancillary studies

  • Methotrexate

    Drug

    Given PO

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Treatment (methotrexate, erlotinib, celecoxib)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
Up to 2 years

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
Up to 3 years
4

Overall survival

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

Time frame
Up to 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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