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

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 (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

• Metastatic Oral Cavity Carcinoma
• Recurrent Oral Cavity Carcinoma
• Stage IVC Lip and Oral Cavity Cancer AJCC v8
• Head and Neck Cancer
• Hypopharynx Cancer
• Oropharynx Cancer
• Clinical Stage IV HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
• Metastatic Hypopharyngeal Carcinoma
• Metastatic Laryngeal Carcinoma
• Metastatic Malignant Head and Neck Neoplasm
• Metastatic Oropharyngeal Carcinoma
• Recurrent Hypopharyngeal Carcinoma
• Recurrent Laryngeal Carcinoma
• Recurrent Malignant Head and Neck Neoplasm
• Recurrent Oropharyngeal Carcinoma
• Stage IVC Hypopharyngeal Carcinoma AJCC v8
• Stage IVC Laryngeal Cancer AJCC v8
• Stage IVC Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Interventions

DRUG

Celecoxib

Given PO

DRUG

Erlotinib Hydrochloride

Given PO

PROCEDURE

Imaging Procedure

Undergo SOC imaging scans

OTHER

Interview

Ancillary studies

DRUG

Methotrexate

Given PO

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

• Mayo Clinic

  lead OTHER

Principal Investigators

• Katharine A. Price, MD · Mayo Clinic in Rochester

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-09

Primary Completion

2028-06-30

Completion

2028-06-30

FDA Drug

Yes

Countries

• United States

Study Locations