Study on Methotrexate, Erlotinib, and Celecoxib for Treating Recurrent or Metastatic Oral Cavity Cancer in Rural Midwest Patients
Sponsor: Mayo Clinic
ClinicalTrials ID:NCT06997068
This clinical trial is exploring a combination of three drugs—methotrexate, erlotinib, and celecoxib—to see if they can safely and effectively treat oral cavity cancer that has returned or spread in patients from rural Midwest areas.
Patient Parameters
| Parameter | Options |
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Program Overview
The purpose of this study is to find out if a combination of three drugs—methotrexate, erlotinib, and celecoxib—can be a safe and effective treatment for oral cavity cancer that has come back or spread to other parts of the body in patients from rural Midwest areas. Methotrexate works by stopping cancer cells from using folic acid, erlotinib blocks a protein that helps cancer cells grow, and celecoxib may stop cancer cells from growing by blocking certain enzymes. The study aims to determine if this combination can help patients with recurrent or metastatic oral cavity cancer.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of oral cavity cancer that has come back or spread.
- Can have either measurable or non-measurable cancer.
- Must have received or be unable to receive standard first-line therapy.
- Be in relatively good health with an ECOG performance status of 0, 1, or 2.
- Have adequate blood counts and organ function based on specific lab tests.
- Women of childbearing potential must have a negative pregnancy test before joining.
- Must be able to swallow pills and complete questionnaires.
- Willing to follow the study schedule and procedures, including treatment and visits.
Exclusion Criteria
- Pregnant or nursing women, or those not using effective birth control.
- Have uncontrolled health issues like recent heart attack, severe heart failure, or serious heart rhythm problems.
- Have active infections or bleeding issues.
- Have mental health or social issues that would prevent following the study.
- Have a weakened immune system or are HIV positive and on treatment.
- Have active hepatitis unless under control with treatment.
- Are taking other investigational drugs for cancer.
- Have another active cancer needing treatment, except for certain cases like treated breast or prostate cancer.
- Have other serious health conditions that would interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic in Rochester | 55905 | Rochester | Minnesota |
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