← Back to Search

Monoclonal Antibodies

Cetuximab for Chordoma

Phase 2
Recruiting
Led By Anthony P Conley, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years
Histologically confirmed diagnosis of advanced (unresectable) and/or metastatic chordoma
Must not have
Clinically relevant coronary artery disease, recent myocardial infarction, high risk of arrhythmia, or uncontrolled cardiac insufficiency
Prior use of an EGFR inhibitor for chordoma treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Summary

This trial is testing cetuximab, a medication that blocks a protein on cancer cells, in adults with advanced or metastatic chordoma. These patients have cancers that cannot be surgically removed or have spread to other parts of the body. The goal is to see if cetuximab can help stop the cancer from growing and spreading. Cetuximab is approved for various cancers including colorectal and head and neck cancers.

Who is the study for?
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.
What is being tested?
The study tests the safety and effectiveness of cetuximab in treating unresectable/metastatic chordoma. It's a phase 2 trial across multiple centers where all participants receive cetuximab. The study includes questionnaires to gather patient-reported outcomes.
What are the potential side effects?
Cetuximab can cause skin reactions like acneiform rash, itching, nail changes; allergic reactions; low magnesium levels; infusion-related reactions such as fever or chills; and rarely lung or heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
My chordoma cannot be removed by surgery and may have spread.
Select...
I have at least one tumor that can be measured on scans.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
I have never used EGFR inhibitors for my chordoma treatment.
Select...
I am either postmenopausal, surgically sterile, or using effective birth control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have serious heart issues, including recent heart attacks or uncontrolled heart failure.
Select...
I have previously used an EGFR inhibitor for my chordoma.
Select...
My cancer has not spread and can be surgically removed.
Select...
I have not had major surgery in the last 4 weeks.
Select...
My blood pressure is not well-managed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall response rate

Side effects data

From 2012 Phase 3 trial • 73 Patients • NCT01177956
43%
Leucopenia
43%
Weight Decreased
40%
Nausea
35%
Rash
34%
Hypomagnesaemia
32%
Hypokalemia
31%
Constipation
28%
Vomiting
28%
Neutropenia
26%
Decreased Appetite
22%
Pyrexia
19%
Hyponatremia
19%
Acne
19%
Hemoglobin Decreased
18%
Stomatitis
18%
Diarrhea
15%
Fatigue
15%
Pruritus
13%
Mucosal Inflammation
13%
Neutrophil Count Decreased
12%
Mouth Ulceration
10%
Insomnia
10%
Thrombocytopenia
10%
Asthenia
9%
Dizziness
9%
Cough
9%
White Blood Cell Count Decreased
7%
Hypocalcaemia
7%
Dermatitis Acneiform
7%
Hypochloremia
7%
Abdominal Pain Upper
7%
Paronychia
7%
Aspartate Aminotransferase Increased
7%
Weight Increased
6%
Neck pain
6%
Dyspnoea
6%
Oral Pain
6%
Headache
3%
Anaphylactic reaction
1%
Microcytic anemia
1%
Mouth hemorrhage
1%
Staphylococcal skin infection
1%
Tumor hemorrhage
1%
Pneumonia
1%
Electrolyte imbalance
1%
Myocardial infarction
1%
Pneumonitis
1%
Pulmonary embolism
1%
Respiratory alkalosis
1%
Toxic encephalopathy
1%
Venous thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase
Cetuximab + Cisplatin + 5-FU : Late Phase

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (cetuximab)Experimental Treatment2 Interventions
Patients receive cetuximab IV over 60-120 minutes QW in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cetuximab
2011
Completed Phase 3
~2480

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Cetuximab, a monoclonal antibody targeting the epidermal growth factor receptor (EGFR), inhibits tumor cell proliferation and survival, making it a significant treatment for Chordoma patients. By blocking EGFR, Cetuximab can potentially slow or halt the growth of Chordoma cells. Other treatments, such as tyrosine kinase inhibitors (TKIs), target growth factor receptors like PDGFRs to inhibit tumor growth and angiogenesis. These targeted therapies are crucial as they disrupt the specific pathways that Chordoma cells depend on, offering a more effective approach to managing advanced or metastatic Chordoma.
Tumor Reduction with Pazopanib in a Patient with Recurrent Lumbar Chordoma.Metastatic squamous cell carcinoma of the anus: time for a shift in the treatment paradigm?The effect of combination anti-endothelial growth factor receptor and anti-vascular endothelial growth factor receptor 2 targeted therapy on lymph node metastasis: a study in an orthotopic nude mouse model of squamous cell carcinoma of the oral tongue.

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,039 Previous Clinical Trials
1,799,686 Total Patients Enrolled
2 Trials studying Chordoma
83 Patients Enrolled for Chordoma
Anthony P Conley, MDPrincipal InvestigatorM.D. Anderson Cancer Center
Anthony P ConleyPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Cetuximab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05041127 — Phase 2
~7 spots leftby Sep 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top