Methotrexate + Erlotinib + Celecoxib for Mouth Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a combination of three drugs—methotrexate, erlotinib, and celecoxib—can safely and effectively treat mouth cancer that has returned after treatment or spread to other parts of the body. Methotrexate stops cancer cells from using a nutrient they need to grow, erlotinib blocks signals that cause tumor cells to multiply, and celecoxib may inhibit cancer growth by blocking certain enzymes. This trial is suitable for individuals in rural Midwest areas diagnosed with recurrent or metastatic oral cavity cancer who have undergone some form of initial treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of methotrexate, erlotinib, and celecoxib has been studied before. In some studies, using these drugs together helped 60% of patients with oral cancers, indicating that many patients handled the treatment well.
However, some long-term results have been less encouraging. Another study found that the effectiveness of this combination decreased over time. While this doesn't directly address safety, it suggests ongoing research aims to improve results.
Regarding safety, another study examined similar treatments and found that small, regular doses of celecoxib and methotrexate improved certain survival measures. This suggests that the treatment is generally well-tolerated when given in smaller doses over time.
This trial is in Phase 2, focusing on learning more about safety and effectiveness. So far, evidence suggests that the drugs can be used safely, but researchers are still determining the best way to use them together.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this combination treatment for mouth cancer because it uniquely targets the disease using three different mechanisms. Methotrexate is a chemotherapy drug that stops cancer cells from growing, erlotinib is a targeted therapy that blocks signals needed for cancer cell growth, and celecoxib is an anti-inflammatory that may help reduce cancer-related inflammation. This multi-faceted approach could potentially enhance effectiveness compared to standard treatments like surgery, radiation, and single-agent chemotherapy, offering a more comprehensive attack on the cancer cells.
What evidence suggests that this trial's treatments could be effective for mouth cancer?
Studies have shown that a combination of three drugs—methotrexate, erlotinib, and celecoxib—can effectively treat oral cavity cancer that hasn't responded to standard treatments. In this trial, participants will receive this combination therapy. Research suggests that this combination may help patients live longer without their cancer worsening and may improve overall survival compared to other treatments. Methotrexate stops cancer cells from using a nutrient they need to grow. Erlotinib blocks a protein that signals cancer cells to multiply, slowing or stopping their spread. Celecoxib may block substances that cancer cells need to grow. These findings suggest this treatment could benefit patients with recurring or spreading oral cavity cancer.24567
Who Is on the Research Team?
Katharine A. Price, MD
Principal Investigator
Mayo Clinic in Rochester
Are You a Good Fit for This Trial?
This trial is for rural Midwest U.S. patients with oral cavity cancer that has either returned after treatment or spread to other body parts. Participants should have a specific type of thyroid or mouth cancer, including cancers of the lip and oral cavity.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive methotrexate, erlotinib, and celecoxib in 28-day cycles for up to 2 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for progression-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Celecoxib
- Erlotinib
- Methotrexate
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor