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.
Additional locations may be listed on ClinicalTrials.gov for NCT06997068.
Locations matching your search criteria
United States
Minnesota
Rochester
Mayo Clinic in RochesterStatus: Active
Contact: Katharine Andress Rowe Price
Phone: 507-284-2511
PRIMARY OBJECTIVES:
I. Demonstrate the feasibility of conducting a decentralized therapeutic clinical trial of triple oral metronomic therapy using methotrexate, erlotinib, and celecoxib in patients with recurrent/metastatic (R/M) oral cavity cancer (OCC) in a largely rural population. Specifically, we plan to assess feasibility in the following ways:
Ia. Evaluate the rates of provider referral and patient enrollment and capture the provider/patient reasons for declining trial participation;
Ib. Evaluate rate of retention and capture the reasons for trial drop-out;
Ic. Assess adherence to treatment and reasons for deviation through qualitative and semiquantitative means;
Id. Define the rate of conversion from virtual to in-person visits, capture the provider/patient reasons for the switch and quantify the out-of-pocket costs of in-person and virtual visits.
SECONDARY OBJECTIVES:
I. Explore the safety and efficacy of the triple oral metronomic chemotherapy regimen of methotrexate, erlotinib, and celecoxib (MEC) in a Midwest United States population with R/M OCC.
Ia. Determine the objective response rate to MEC;
Ib. Determine progression-free survival and overall survival;
Ic. Evaluate the safety and toxicity of MEC.
OTHER OBJECTIVES:
I. Compare treatment cost for patients receiving MEC with a parallel cohort receiving standard of care (SOC) in-person treatment.
II. Evaluate patient impact of decentralized trial treatment through qualitative and semi-quantitative methods including surveys and patient interviews.
III. Investigate the impact of patient socioeconomic status on patient related outcomes.
OUTLINE:
Patients receive methotrexate orally (PO) on days 1, 8, 15, and 22 of each cycle, erlotinib PO once daily (QD) on days 1-28 of each cycle, and celecoxib PO twice daily (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.
After completion of study treatment, patients are followed up at 30 days and then every 3 months until disease progression (if applicable) and/or every 6 months after disease progression for 3 years.
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorKatharine Andress Rowe Price
