Actively Recruiting
Decentralized Pilot Study of Oral Methotrexate, Erlotinib, and Celecoxib for Recurrent/Metastatic Head and Neck Cancer in Rural Midwest United States
Led by Mayo Clinic · Updated on 2026-05-11
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, feasibility, and effects of combining methotrexate, erlotinib, and celecoxib to treat recurrent or metastatic head and neck cancer in patients from rural Midwest areas. This phase II trial focuses on patients whose cancer has returned after improvement or spread from its original site. The study aims to better understand how these three oral drugs might work together to slow or stop tumor growth in this specific population. Participants receive methotrexate by mouth on days 1, 8, 15, and 22 of each 28-day cycle, erlotinib daily on days 1 through 28, and celecoxib twice daily during days 1 to 28. These cycles repeat every 28 days for up to two years unless the disease worsens or side effects become unacceptable. Standard imaging scans are performed throughout the study to monitor the cancer's status. During the trial, patients will undergo regular assessments including imaging and questionnaires, as well as interviews for additional studies. Researchers will track measures like feasibility based on referral, enrollment, retention, and visit types over two years. They will also monitor adverse events up to 30 days after treatment and evaluate tumor response, progression-free survival, and overall survival for up to three years. Participants must attend scheduled visits, complete questionnaires, and adhere to the treatment plan throughout the study period.
CONDITIONS
Brief Title
Methotrexate, Erlotinib, and Celecoxib for the Treatment of Recurrent/Metastatic Head and Neck Cancer in a Rural Midwest United States Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed relapsed or metastatic head and neck cancer including oral cavity, oropharynx (HPV positive or negative), hypopharynx, and larynx cancer
- Measurable or non-measurable disease as defined by RECIST criteria
- Received standard first-line immunotherapy or chemo-immunotherapy OR unable to receive or refuse first-line therapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Hemoglobin level of at least 9.0 g/dL within 15 days prior to registration
- Absolute neutrophil count (ANC) of at least 1500/mm³ within 15 days prior to registration
- Platelet count of at least 100,000/mm³ within 15 days prior to registration
- Total bilirubin no more than 1.5 times the upper limit of normal (ULN) within 15 days prior to registration
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) levels no more than 3 times ULN (or 5 times ULN for patients with liver involvement) within 15 days prior to registration
- Prothrombin time (PT), international normalized ratio (INR), and activated partial thromboplastin time (aPTT) no more than 1.5 times ULN or within target range if on anticoagulants within 15 days prior to registration
- Calculated creatinine clearance of at least 45 ml/min using CKD-EPI equation within 15 days prior to registration
- Negative pregnancy test within 8 days prior to registration for persons of childbearing potential
- Provide written informed consent
- Ability to complete questionnaires independently or with assistance
- Ability to swallow pills
- Willingness and ability to follow study schedule including treatments and visits
You will not qualify if you...
- Pregnant or nursing persons
- Persons of childbearing potential or able to father a child unwilling to use adequate contraception
- Uncontrolled illnesses such as recent myocardial infarction (within 6 months), severe heart failure (NYHA class III or IV), prolonged QT interval, uncontrolled heart rhythm problems, serious ventricular arrhythmias, active infections needing treatment, or active gastrointestinal bleeding
- Psychiatric or social conditions limiting study compliance
- Immunocompromised patients or HIV positive patients currently on antiretroviral therapy
- Known hepatitis infection unless controlled or cured as specified
- Receiving other investigational treatments for primary cancer
- Other active cancers requiring treatment except hormonal therapy for breast or prostate cancer if eligible
- Severe co-morbid illnesses or conditions that may interfere with safety assessment or study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive oral methotrexate on days 1, 8, 15, and 22 of each 28-day cycle, erlotinib daily on days 1-28, and celecoxib twice daily on days 1-28 of each cycle. Treatment cycles repeat every 28 days for up to 2 years unless disease progression or unacceptable toxicity occurs. Participants also undergo standard-of-care imaging scans during treatment.
Weekly visits for up to 2 years
Duration - Up to 3 years
Participants are monitored for safety and outcomes such as adverse events, response to treatment, progression-free survival, and overall survival after completing treatment.
Visits as scheduled for assessments up to 3 years
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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