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

StatusRecruiting
PhasePhase 2
Started2025-08-07
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 13 months later Jun 30, 2028 → Aug 5, 2029
See other at-risk trials from Mayo Clinic

Amendment history

2026-10-02
Primary completion pushed: 2028-06-30 → 2029-08-05
Completion pushed: 2028-06-30 → 2029-08-05
2026-05-07
Study Status, Conditions, Eligibility v6
Eligibility criteria+23 characters
[...] tic head and neck cancer, including oral cavity, oropharynx [human papillomavirus (NPVHPV) positive and negative), hypopharynx, and larynx cancer Meas [...]
2026-04-23
Study Identification, Study Status, Study Description, Conditions, Eligibility v5
Eligibility criteria+97 characters
Inclusion Criteria: Age ≥ 18 years Histologically confirmed diagnosis of relapsed/metastatic head and neck cancer, including oral cavity, oropharynx (NPV positive and negative), hypopharynx, and larynx cancer Measurable or non-measurable disease is allowed Meas [...]
Study title+2 characters
Methotrexate, Erlotinib, and Celecoxib for the Treatment of Recurrent/Metastatic OralHead Cavityand Neck Cancer in a Rural Midwest United States Population
2026-04-14
2 amendments v3-v4
2 re-verifications since 2026-04-01, no change to tracked fields
2025-07-09
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-09-19→confirmed 2025-07-09
Study sitesdetails revised at 1 of 1 site
2025-07-02
Study Status, Oversight v1
Start date2025-06-19→2025-09-19
2025-05-21
Original filing
Mayo Clinic
1,015 trials monitored
See 115 trials at risk
Head & Neck Cancer
2,051 trials monitored
See 116 trials at risk
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.
Trial Details
NCT Number NCT06997068
Lead Sponsor Mayo Clinic
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 +10 more
Enrollment 25 participants
Start Date 2025-08-07
Primary Completion 2029-08-05 (estimated)
Study Completion 2029-08-05 (estimated)
Updated on ClinicalTrials.gov 2026-10-01