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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT06997068
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Celecoxib — DRUG
    Given PO
  • Erlotinib Hydrochloride — DRUG
    Given PO
  • Imaging Procedure — PROCEDURE
    Undergo SOC imaging scans
  • Interview — OTHER
    Ancillary studies
  • Methotrexate — DRUG
    Given PO
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

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.

Key Dates

Start date
Jul 9, 2025
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (methotrexate, erlotinib, celecoxib)
    Patients receive methotrexate PO on days 1, 8, 15, and 22 of each cycle, erlotinib PO QD on days 1-28 of each cycle, and celecoxib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. Patients also undergo SOC imaging scans throughout the trial.

Primary Outcome Measure

Rates of provider referral and patient enrollment (Feasibility) [ Time Frame: Up to 2 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905
Clinical Trials Referral Office
[email protected]
855-776-0015
Katharine A. Price, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Mayo Clinic in Rochester· Rochester, MN

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