deltatrials
Recruiting INTERVENTIONAL NCT06997068

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

MC240701 Decentralized Pilot Study of Triple Oral Metronomic Chemotherapy for Patients With Recurrent/Metastatic Head and Neck Cancer in a Rural Midwest United States Population

Sponsor: Mayo Clinic

Updated 4 times since 2025 Last updated: Apr 23, 2026 Started: Jul 9, 2025 Primary completion: Jun 30, 2028 Completion: Jun 30, 2028
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This observational or N/A phase trial investigates Head and Neck Cancer and Hypopharynx Cancer and is currently actively recruiting participants. Mayo Clinic leads this study, which shows 4 recorded versions since 2025 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jun 2025 – ~Aug 2025 · 2 months · monthly snapshotNot Yet Recruiting~Aug 2025 – ~Apr 2026 · 9 months · monthly snapshotRecruitingApr 18, 2026 – May 4, 2026 · 16 days · daily APIRecruitingMay 4, 2026 – present · 2 months · daily APIRecruiting

Change History

4 versions recorded
  1. May 4, 2026 — Present [daily]

    Recruiting

  2. Apr 18, 2026 — May 4, 2026 [daily]

    Recruiting

    Phase: PHASE2None

  3. Aug 2025 — Apr 2026 [monthly]

    Recruiting PHASE2

    Status: Not Yet RecruitingRecruiting

  4. Jun 2025 — Aug 2025 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility 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.

Contact Information

Sponsor contact:
  • Mayo Clinic
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations