Cetuximab for the Treatment of Advanced Unresectable or Metastatic Chordoma

General information

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 12 years or older with locally advanced or metastatic tumors. It will soon 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 disease.

Who can participate

This trial is designed for chordoma patients ages 12 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 therapy

• No prior use of an EGFR inhibitor

• Age 12 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.