Cetuximab for Chordoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests cetuximab to determine its effectiveness in treating advanced or metastatic chordoma, a rare bone cancer that is difficult to remove surgically. The goal is to assess cetuximab's effectiveness and safety for these patients. Individuals with chordoma that cannot be surgically removed or has spread might be suitable candidates, especially if they have not previously received similar treatments. Participants will receive cetuximab through an IV once a week, provided their condition remains stable and they tolerate the treatment well. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires a washout period (time without taking certain medications) of at least 3 weeks from any systemic therapy (like small molecule/targeted agents or immunotherapies) and/or radiation therapy before starting the study. It does not specify about other medications, so you should discuss your current medications with the study team.
Is there any evidence suggesting that cetuximab is likely to be safe for humans?
Research has shown that cetuximab, a treatment being tested for chordoma, has been studied for safety and tolerability in earlier trials. The FDA has already approved cetuximab for other types of cancer, indicating its safety for humans. Studies have found that most people tolerate cetuximab well, though some may experience side effects like skin reactions or infusion reactions, which are usually manageable. This trial aims to build on existing evidence to evaluate cetuximab's effectiveness specifically in patients with advanced or metastatic chordoma.12345
Why do researchers think this study treatment might be promising for chordoma?
Unlike most treatments for chordoma, which typically involve surgery and radiation, cetuximab offers a different approach by targeting the epidermal growth factor receptor (EGFR), a protein that can promote cancer cell growth. This mechanism of action is unique because it directly interferes with the cancer cells' ability to grow and divide, potentially slowing or stopping tumor progression. Researchers are excited about cetuximab because targeting EGFR could lead to more effective management of chordoma, especially in cases where traditional treatments are not viable or have failed.
What evidence suggests that cetuximab might be an effective treatment for chordoma?
Research shows that cetuximab, the treatment under study in this trial, might help shrink or stop the growth of chordoma tumors, a rare and difficult-to-treat bone cancer. Earlier studies have shown that cetuximab helps the body's immune cells attack these cancer cells. The treatment targets specific proteins on the cancer cells, making it easier for the immune system to find and destroy them. Although detailed data on its effectiveness for chordoma patients is still being collected, early results suggest that cetuximab could be a promising option for those with advanced chordoma or when the cancer has spread to other parts of the body.12456
Who Is on the Research Team?
Anthony P. Conley, MD
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic chordoma, a type of cancer. Participants must be at least 18 years old, have a life expectancy over 3 months, and not have used EGFR inhibitors before. They should have measurable disease by scans and good organ function. Women must use effective contraception or be non-childbearing.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cetuximab IV over 60-120 minutes weekly in the absence of disease progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cetuximab
Cetuximab is already approved in United States, European Union for the following indications:
- Locally or regionally advanced squamous cell carcinoma of the head and neck
- Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck
- K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
- BRAF V600E mutation-positive metastatic colorectal cancer
- Squamous cell carcinoma of the head and neck
- K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor