Cetuximab
Cetuximab for the Treatment of Advanced Unresectable or Metastatic Chordoma
Summary
This Phase 2 trial is studying the effectiveness of a targeted cancer therapy called cetuximab (Erbitux®). Cetuximab targets the EGFR protein, which is believed to be involved in driving the growth of chordoma tumors. This study is designed specifically for chordoma patients ages 18 years or older with locally advanced or metastatic tumors. It is now open at The University of Texas MD Anderson Cancer Center in Houston, Texas. The principal investigator for this study is Dr. Anthony Conley.
Why this trial is being done
Epidermal growth factor receptor (EGFR) is a protein found on the surface of certain cells throughout the body. Ordinarily, EGFR helps to regulate cell growth and plays a role in wound healing. In certain cancers, including most chordomas, higher than normal amounts of EGFR protein lead the cancer cells to multiply out of control. Drugs that target EGFR, called EGFR inhibitors, are approved to treat several different types of cancer. Cetuximab is currently approved to treat metastatic colorectal cancer, squamous cell cancer of the head and neck, non-small cell lung cancer, and squamous cell skin cancer. Research in multiple labs around the world has revealed that EGFR plays an important role in driving the growth of many chordoma tumors and suggests that drugs targeting EGFR could represent a promising treatment approach for chordoma patients. Additionally, cetuximab has demonstrated an impressive ability to stop or even shrink chordoma tumors in mice in experiments conducted through the Foundation’s Drug Screening Program. And, to date, there have been three published case reports of chordoma patients benefiting from treatment with cetuximab. This trial aims to determine whether cetuximab can shrink or stop the growth of chordoma tumors in patients with locally advanced or metastatic diseaseWhen tumors have spread to other parts of the body from the original tumor site..
Who can participate
This trial is designed for chordoma patients ages 18 years or older. Patients must meet the following criteria to be eligible:
- Confirmed diagnosis of chordoma
- Locally advanced (cannot be treated with surgery) or metastatic disease confirmed by imaging (must have at least one site of measurable disease)
- At least 4 weeks since major surgery
- At least 3 weeks since radiation or prior systemic therapyThe use of drugs that spread through the body to kill cancer cells. Also called chemotherapy or drug therapy.
- No prior use of an EGFR inhibitor
- Age 18 years or older
- No major laboratory abnormalities
- Willing and able to travel to the enrolling study site for all treatment and follow-up visits
Full eligibility criteria can be found at ClinicalTrials.gov.
How the trial will work
- Participants will receive 500 mg/m2 IV infusions once every 2 weeks until there is tumor growth, severe side effects or change in health, or the participant leaves the trial.
- Check-up exams will be performed every 4 weeks and imaging done every 8 weeks.
- All exams, treatments, and evaluations are provided at the trial site where the patient enrolled in the study. Participants not local to the trial site MUST be willing and able to travel to their trial site for all visits required by the trial.
How to enroll in this trial
The trial team will see all potential patients in a clinic visit before beginning the enrollment process. See the FAQ, “How do I find out if I’m eligible to participate?”, below for more specific information on enrolling.
FAQs
What are the costs to participate in the trial?
The study treatment, cetuximab, is provided at no cost to participants. Participants and their insurance provider are responsible for the cost of check-ups and imaging done within the study, as this is considered standard of care. Any other medical care needed while on the trial will be the responsibility of the patient or the patient’s insurance. Trial participants from out of town are responsible for any travel or lodging expenses necessary to make the required clinic visits every 2 weeks. The trial site may partner with local hotels to provide discounted rates to out-of-town patients.
What are the downsides of participating in the trial?
Side effects from systemic therapies like cetuximab are possible. Talking with your doctor or the trial investigators is the best way to learn about the risks of this particular treatment and of participating in this trial.
How do I find out if I'm eligible to participate?
If you and your doctor decide that this trial might be right for you, the next step is to contact the trial team. Contact Li Li, PhD (
LLi8@mdanderson.org | +1 (713) 794-5961) or Josephine Charles (
JJCharles@mdanderson.org | +1 (713) 745-5682). The team will let you know where to send your medical records and what you can expect as next steps. One of these steps will be the
informed consentThe process during which patients are given complete information about a treatment or clinical trial, including possible risks and benefits, so they can decide whether to have the treatment or participate in the trial. For clinical trials, this includes patient rights, including the ability to withdraw consent and leave the trial at any time. process, during which the team will fully explain all aspects of the trial including any potential benefits and risks, and whether you are eligible.
How effective is cetuximab?
It is not currently known how effective cetuximab is for the treatment of chordoma. One goal of this study is to determine the initial effectiveness of cetuximab for treating chordoma.
How is the treatment given?
Study participants are given an intravenousAny fluids given inside a vein. These could be treatment, medications, blood, or contrast dye for MRI and CT scans. (IV) infusion of cetuximab once every two weeks during a clinic visit at the trial site.
What check-ups are involved during the study?
Regular check-ups are done at the trial clinic every 4 weeks, and MRIA type of imaging scan that is used initially to help diagnose chordoma, as well as during follow up to check for recurrence or metastasis. is done every 8 weeks. More check-ups may be scheduled if your health status requires it.
How long will I be in this study?
You may continue receiving cetuximab as long as your tumor doesn’t grow and you don’t experience unacceptable side effects. After you complete the study or stop the treatment, the trial team would like to continue to check in with you, but you can stop participating at any time and for any reason.
I don’t live near the trial site. Can I still participate in the trial?
All exams, treatments, and evaluations are provided at MD Anderson Cancer Center in Houston. Patients not local to the trial site MUST be willing and able to travel to MD Anderson for all visits required by the study. Travel and lodging expenses are the responsibility of the patient.
Are there any resources available to help with lodging and travel?
The
Lazarex Cancer Foundation provides assistance specifically to help make it possible for people to participate in clinical trials. They provide financial assistance for travel and lodging costs as well as any costs associated with the trial that are not covered by insurance. Additionally, MD Anderson has a lot of helpful information on their website regarding resources related to both lodging and travel. Links to these resources are provided below, and you are encouraged to visit the Helpful resources page of our website as well. Hotels with discounted rates for MD Anderson patients Apartments Rotary House International Additional lodging options MD Anderson Patient Travel Services If you cannot travel to MD Anderson, you may also be able to receive cetuximab outside of this trial if your doctor prescribes it off-labelThe practice of prescribing drug treatments that are not approved by government agencies to treat a particular disease. Doctors are allowed to prescribe drugs off-label if they believe it is in the best interest of the patient.; however, it is unlikely to be fully covered by insurance or healthcare systems.
What happens if I decide to leave the trial and stop taking the drug?
You always have the option to stop treatment on a clinical trialResearch studies involving human subjects that are done to test whether a treatment is safe, and how well it will work to treat a specific disease.. If you decide to stop treatment for any reason, the study investigators will follow-up with you every 3 months (for up to 2 years) so they can monitor side effects and understand how well the treatment worked.
What happens if my tumor grows while enrolled in the study?
If your tumor grows while you are enrolled in the study the trial doctor will discuss other treatment options with you but you will no longer be able to participate in the study.
If you are unable to participate in this trial, there may be other trials available to you. See our Clinical Trials Catalogue for a listing of other trials accepting chordoma patients. If you have more questions about this trial or other clinical trials that may be options for chordoma patients, please contact a Chordoma Foundation Patient Navigator for assistance.
Contact a Patient Navigator »
Medical information provided by the Chordoma Foundation in any medium is for informational and educational purposes only. After reading content from the Chordoma Foundation, review the information carefully with your physician. Information from the Chordoma Foundation is not a substitute for consultations with qualified health care professionals who are familiar with your medical conditions and needs. The Chordoma Foundation strongly recommends that care and treatment decisions be made in consultation with your physician or other qualified health care professionals who are familiar with your specific health situation.
