RECRUITING

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

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Conditions

Metastatic Oral Cavity CarcinomaRecurrent Oral Cavity CarcinomaStage IVC Lip and Oral Cavity Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Decentralized Pilot Study of Triple Oral Metronomic Chemotherapy for Patients With Recurrent/Metastatic Oral Cavity Cancer in a Rural Midwest United States Population

Quick Facts

Study Start:2025-07-09
Study Completion:2028-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06997068

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years
  2. * Histologically confirmed diagnosis of relapsed/metastatic oral cavity cancer
  3. * Measurable or non-measurable disease is allowed
  4. * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
  5. * Non-measurable disease
  6. * NOTE: Other nonmeasurable lesions include clinically evident lesions not well visualized on imaging \[e.g., oral cavity mass readily seen on physical exam but obscured on computed tomography (CT)\], dermal metastases, and bone metastases
  7. * Prior treatment:
  8. * One of the following must be true:
  9. * Received standard 1st-line immunotherapy or chemo-immunotherapy OR
  10. * Unable to receive or refuse 1st-line therapy
  11. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
  12. * Hemoglobin ≥ 9.0 g/dL (obtained 15 days prior to registration)
  13. * Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained 15 days prior to registration)
  14. * Platelet count ≥ 100,000/mm\^3 (obtained 15 days prior to registration)
  15. * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained 15 days prior to registration)
  16. * Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained 15 days prior to registration)
  17. * Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN OR if patient is receiving anticoagulant therapy and INR or aPTT is within target range of therapy (obtained 15 days prior to registration)
  18. * Calculated creatinine clearance ≥ 45 ml/min per Chronic-Kidney Disease-Epidemiology (CKD-EPI) Creatinine Equation (obtained 15 days prior to registration)
  19. * Estimated creatinine clearance (Clcr) by the CKD-EPI Creatinine Equation (per National Kidney Foundation) (obtained 15 days prior to registration)
  20. * Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only
  21. * Provide written informed consent
  22. * Ability to complete questionnaire(s) by themselves or with assistance
  23. * Ability to swallow pills
  24. * Willing and able to adhere with the protocol schedule for the duration of the study including undergoing treatment, attending scheduled visits, and examinations
  1. * Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown
  2. * Pregnant persons
  3. * Nursing persons
  4. * Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception
  5. * Uncontrolled intercurrent illness including, but not limited to:
  6. * Myocardial infarction ≤ 6 months prior to registration
  7. * New York Heart Association (NYHA) class III or IV heart failure
  8. * Corrected QT interval (QTc) prolongation more than 440 ms in males and 460 ms in females
  9. * Uncontrolled dysrhythmias or poorly controlled angina
  10. * History of serious ventricular arrhythmia \[ventricular tachycardia (VT) or ventricular flutter (VF)\] and/or factors that predispose to arrhythmia (e.g., heart failure, hypokalemia, family history of long QT syndrome)
  11. * Ongoing or active infection requiring systemic treatment
  12. * Active gastrointestinal bleeding
  13. * Psychiatric illness/social situations that would limit compliance with study requirements
  14. * Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy
  15. * NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
  16. * Known hepatitis
  17. * Exception: For patients with evidence of chronic hepatitis B virus infection the hepatitis B (HepB) viral load must be undetectable on suppressive therapy, if indicated, to be eligible
  18. * Exception: Patients with a history of hepatitis C virus infection must have been treated and cured. Patients with hepatitis C virus (HCV) infection who are currently on treatment are eligible if they have an undetectable HCV viral load
  19. * Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  20. * Other active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy. Patients on hormonal therapy for treated breast or prostate cancer are permitted if they meet other eligibility criteria
  21. * NOTE: Patients with secondary malignancy with life expectancy ≥ 2 years are eligible
  22. * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Katharine A. Price, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Katharine A. Price, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-09
Study Completion Date2028-06-30

Study Record Updates

Study Start Date2025-07-09
Study Completion Date2028-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Metastatic Oral Cavity Carcinoma
  • Recurrent Oral Cavity Carcinoma
  • Stage IVC Lip and Oral Cavity Cancer AJCC v8