Methotrexate with erlotinib and celecoxib for recurrent or metastatic head and neck cancer in rural Midwest patients
MC240701 Decentralized Pilot Study of Triple Oral Metronomic Chemotherapy for Patients With Recurrent/Metastatic Head and Neck Cancer in a Rural Midwest United States Population
This trial tests whether combining methotrexate, erlotinib, and celecoxib can help adults in the rural Midwest whose head and neck cancer has returned or spread.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation, erlotinib, methotrexate |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06997068 on ClinicalTrials.gov |
What this trial studies
This Phase II trial gives a combination of methotrexate, erlotinib, and celecoxib to adults with recurrent or metastatic head and neck cancers recruited largely from the rural Midwest. Participants may have measurable or non-measurable disease and must have previously received first-line immunotherapy/chemo-immunotherapy or be unable to receive or refuse such therapy, with ECOG performance status 0–2 and required lab thresholds. The study uses imaging, clinical interviews, safety labs, and RECIST criteria to monitor feasibility, tolerability, and anti-tumor effect. Treatment includes oral erlotinib and celecoxib combined with methotrexate administration and regular follow-up visits for response and safety assessments.
Who should consider this trial
Good fit: Ideal candidates are adults from the rural Midwest with histologically confirmed recurrent or metastatic head and neck cancer who have received (or are unable to receive) standard first-line immunotherapy, have ECOG 0–2, and meet baseline blood-count and organ-function criteria.
Not a fit: Patients with ECOG performance status greater than 2, significant organ dysfunction, uncontrolled infections, pregnancy, or those planning standard first-line curative therapy are unlikely to benefit from this regimen.
Why it matters
Potential benefit: If successful, the combination could offer a tolerable, clinic-deliverable option that slows tumor growth and improves symptom control for patients with recurrent or metastatic head and neck cancer.
How similar studies have performed: Prior single-agent and combination studies have shown modest activity for methotrexate or EGFR inhibitors in recurrent head and neck cancer, but adding celecoxib is relatively untested and clear benefit is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* Age ≥ 18 years
* Histologically confirmed diagnosis of relapsed/metastatic head and neck cancer, including oral cavity, oropharynx \[human papillomavirus (HPV) positive and negative), hypopharynx, and larynx cancer
* Measurable or non-measurable disease is allowed
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
* Non-measurable disease
* 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
* Prior treatment:
* One of the following must be true:
* Received standard 1st-line immunotherapy or chemo-immunotherapy OR
* Unable to receive or refuse 1st-line therapy
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1 or 2
* Hemoglobin ≥ 9.0 g/dL (obtained 15 days prior to registration)
* Absolute neutrophil count (ANC) ≥ 1500/mm\^3 (obtained 15 days prior to registration)
* Platelet count ≥ 100,000/mm\^3 (obtained 15 days prior to registration)
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained 15 days prior to registration)
* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained 15 days prior to registration)
* 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)
* Calculated creatinine clearance ≥ 45 ml/min per Chronic-Kidney Disease-Epidemiology (CKD-EPI) Creatinine Equation (obtained 15 days prior to registration)
* Estimated creatinine clearance (Clcr) by the CKD-EPI Creatinine Equation (per National Kidney Foundation) (obtained 15 days prior to registration)
* Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only
* Provide written informed consent
* Ability to complete questionnaire(s) by themselves or with assistance
* Ability to swallow pills
* Willing and able to adhere with the protocol schedule for the duration of the study including undergoing treatment, attending scheduled visits, and examinations
Exclusion Criteria:
* 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
* Pregnant persons
* Nursing persons
* Persons of childbearing potential and persons able to father a child who are unwilling to employ adequate contraception
* Uncontrolled intercurrent illness including, but not limited to:
* Myocardial infarction ≤ 6 months prior to registration
* New York Heart Association (NYHA) class III or IV heart failure
* Corrected QT interval (QTc) prolongation more than 440 ms in males and 460 ms in females
* Uncontrolled dysrhythmias or poorly controlled angina
* 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)
* Ongoing or active infection requiring systemic treatment
* Active gastrointestinal bleeding
* Psychiatric illness/social situations that would limit compliance with study requirements
* Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy
* NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
* Known hepatitis
* 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
* 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
* Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
* 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
* NOTE: Patients with secondary malignancy with life expectancy ≥ 2 years are eligible
* 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
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Katharine A. Price, MD — Mayo Clinic in Rochester
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.