Methotrexate + Erlotinib + Celecoxib for Mouth Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Must not be taking: Antiretrovirals, Investigational agents

Disqualifiers: Pregnancy, Heart failure, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

25 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Katharine A. Price, MD

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

This trial is for rural Midwest U.S. patients with oral cavity cancer that has either returned after treatment or spread to other body parts. Participants should have a specific type of thyroid or mouth cancer, including cancers of the lip and oral cavity.

Inclusion Criteria

Ability to swallow pills

Estimated creatinine clearance (Clcr) by the CKD-EPI Creatinine Equation

My cancer in the mouth has returned or spread.

Exclusion Criteria

I am not receiving cancer treatment, except hormone therapy for breast or prostate cancer.

I have been diagnosed with hepatitis.

Receiving any other investigational agent for the primary neoplasm

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive methotrexate, erlotinib, and celecoxib in 28-day cycles for up to 2 years

Up to 2 years

Monthly visits for each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 30 days after completion of study treatment

Long-term follow-up

Participants are monitored for progression-free survival and overall survival

Up to 3 years

Treatment Details

Interventions

• Celecoxib
• Erlotinib
• Methotrexate

Trial Overview The study tests a combination of three drugs: Methotrexate, Erlotinib Hydrochloride, and Celecoxib for recurrent/metastatic oral cavity cancer. It includes imaging procedures and questionnaires to assess feasibility, safety, and effectiveness.

Participant Groups

Group I: Treatment (methotrexate, erlotinib, celecoxib) Experimental Treatment 6 Interventions

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.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+