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NCT06997068 · ClinicalTrials.gov registry record · Phase 2
Methotrexate, Erlotinib, and Celecoxib for the Treatment of Recurrent/Metastatic Oral Cavity Cancer in a Rural Midwest United States Population
A Phase 2 study of Metastatic Oral Cavity Carcinoma and Recurrent Oral Cavity Carcinoma, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT06997068: Recruiting Phase 2 study of Metastatic Oral Cavity Carcinoma and Recurrent Oral Cavity Carcinoma, sponsored by Mayo Clinic.
NCT06997068 is a Phase 2 study of Metastatic Oral Cavity Carcinoma and Recurrent Oral Cavity Carcinoma that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06997068, a Phase 2 study of Metastatic Oral Cavity Carcinoma and Recurrent Oral Cavity Carcinoma, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Will capture the provider/patient reasons for declining trial participation. All information will be described descriptively. Categorical variables will be described with frequencies and percentages. Continuous variables will be described with means, medians, standard deviations, etc.
Conditions Studied
Interventions
- DRUG Celecoxib
- PROCEDURE Imaging Procedure
- OTHER Interview
- DRUG Methotrexate
- DRUG Erlotinib Hydrochloride
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2025-07-09 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 2 |
What NCT06997068 shows while recruiting
NCT06997068 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 3 conditions, with Metastatic Oral Cavity Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Celecoxib is the first listed.
NCT06997068 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT06997068 about?
NCT06997068 is a clinical study titled "Methotrexate, Erlotinib, and Celecoxib for the Treatment of Recurrent/Metastatic Oral Cavity Cancer in a Rural Midwest United States Population". 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...
What is the current status of trial NCT06997068?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2025-07-09. Estimated completion is 2028-06-30.
What conditions does trial NCT06997068 study?
This clinical trial studies the following conditions: Metastatic Oral Cavity Carcinoma, Recurrent Oral Cavity Carcinoma, Stage IVC Lip and Oral Cavity Cancer AJCC v8.
What interventions are being tested in trial NCT06997068?
The interventions under investigation include: Celecoxib (DRUG), Imaging Procedure (PROCEDURE), Interview (OTHER), Methotrexate (DRUG), Erlotinib Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT06997068?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06997068 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06997068's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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