Trials / Recruiting
RecruitingNCT06997068
Methotrexate, Erlotinib, and Celecoxib for the Treatment of Recurrent/Metastatic Oral Cavity Cancer in a Rural Midwest United States Population
MC240701 Decentralized Pilot Study of Triple Oral Metronomic Chemotherapy for Patients With Recurrent/Metastatic Oral Cavity Cancer in a Rural Midwest United States Population
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Metastatic Oral Cavity Carcinoma
- Recurrent Oral Cavity Carcinoma
- Stage IVC Lip and Oral Cavity Cancer AJCC v8
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2025-07-09
- Primary completion
- 2028-06-30
- Completion
- 2028-06-30
- First posted
- 2025-05-30
- Last updated
- 2026-04-17
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06997068. Inclusion in this directory is not an endorsement.