Is NCT06997068 recruiting in Rochester, MN?

Yes, NCT06997068 is currently recruiting participants at its Rochester, MN location. This metastatic oral cavity carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Rochester clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Metastatic Oral Cavity Carcinoma Clinical Trial in Rochester, MN

Q: How do I join the metastatic oral cavity carcinoma clinical trial in Rochester?

To join this clinical trial in Rochester, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Metastatic Oral Cavity Carcinoma Study in Rochester

This phase II trial gathers information on the feasibility, safety, and effect of giving methotrexate, erlotinib, and celecoxib in treating head and neck 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 head and neck cancer.

Sponsor: Mayo Clinic

Who Can Participate

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Rochester?

Yes, this clinical trial (NCT06997068) has an active research site in Rochester, MN that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Metastatic Oral Cavity Carcinoma Treatment Options in Rochester, MN

If you're searching for metastatic oral cavity carcinoma treatment options in Rochester, MN, this clinical trial (NCT06997068) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Rochester research site is actively enrolling participants for this clinical trial. You'll receive care from experienced metastatic oral cavity carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all metastatic oral cavity carcinoma clinical trials near you to find additional studies recruiting in your area.

Metastatic Oral Cavity Carcinoma Clinical Trial in Rochester, MN

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