OncoMatch/Clinical Trials/NCT06997068
Methotrexate, Erlotinib, and Celecoxib for the Treatment of Recurrent/Metastatic Oral Cavity Cancer in a Rural Midwest United States Population
Is NCT06997068 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Celecoxib and Erlotinib Hydrochloride for metastatic oral cavity carcinoma.
Treatment: Celecoxib · Erlotinib Hydrochloride · Methotrexate — This phase II trial gathers information on the feasibility, safety, and effect of giving methotrexate, erlotinib, and celecoxib in treating oral cavity 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 oral cavity cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage IVC (AJCC v8)
Metastatic disease required
relapsed/metastatic oral cavity cancer; Stage IVC Lip and Oral Cavity Cancer AJCC v8
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: immunotherapy — first-line
Received standard 1st-line immunotherapy or chemo-immunotherapy
Must have received: chemo-immunotherapy — first-line
Received standard 1st-line immunotherapy or chemo-immunotherapy
Lab requirements
Blood counts
Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1500/mm^3; Platelet count ≥ 100,000/mm^3
Kidney function
Calculated creatinine clearance ≥ 45 ml/min per CKD-EPI Creatinine Equation
Liver function
Total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement)
Cardiac function
Corrected QT interval (QTc) prolongation more than 440 ms in males and 460 ms in females; NYHA class III or IV heart failure; history of serious ventricular arrhythmia
Hemoglobin ≥ 9.0 g/dL; ANC ≥ 1500/mm^3; Platelet count ≥ 100,000/mm^3; Total bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement); Calculated creatinine clearance ≥ 45 ml/min per CKD-EPI Creatinine Equation; Corrected QT interval (QTc) prolongation more than 440 ms in males and 460 ms in females; NYHA class III or IV heart failure; history of serious ventricular arrhythmia
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Rochester · Rochester, Minnesota
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