What side effects are associated with this type of intervention?

Cetuximab, a monoclonal antibody targeting EGFR, is associated with several side effects, including ocular toxicities such as trichomegaly (abnormal eyelash growth), poliosis (whitening of eyelashes), and diffuse punctate keratitis. Other common side effects include skin reactions like acneiform rash, infusion reactions, and gastrointestinal issues such as diarrhea. These side effects are consistent with those observed in other EGFR inhibitors used in cancer treatment.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved drugs for the treatment of chordoma that target EGFR similar to cetuximab. Cetuximab itself is being studied for its efficacy and safety in treating advanced or metastatic chordoma. Generally, treatments for chordoma have included surgical resection, radiation therapy, and various systemic therapies, but targeted therapies like cetuximab are still under investigation.

What other types of research exist?

Promising alternatives to Cetuximab for Chordoma patients include Bevacizumab, which has shown efficacy in reducing tumor growth and improving hearing in NF2-related vestibular schwannomas, and Pembrolizumab, which has demonstrated antitumor activity in various cancers. Additionally, Smoothened (SMO) inhibitors like Vismodegib, used in basal cell carcinoma, may offer potential due to their pathway targeting, though specific efficacy in Chordoma would need further investigation.

← 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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

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%

Pruritus

15%

Fatigue

13%

Mucosal Inflammation

13%

Neutrophil Count Decreased

12%

Mouth Ulceration

10%

Insomnia

10%

Thrombocytopenia

10%

Asthenia

Dizziness

Cough

White Blood Cell Count Decreased

Hypocalcaemia

Dermatitis Acneiform

Hypochloremia

Abdominal Pain Upper

Paronychia

Aspartate Aminotransferase Increased

Weight Increased

Dyspnoea

Neck pain

Oral Pain

Headache

Anaphylactic reaction

Pneumonitis

Microcytic anemia

Mouth hemorrhage

Pneumonia

Electrolyte imbalance

Myocardial infarction

Staphylococcal skin infection

Tumor hemorrhage

Pulmonary embolism

Respiratory alkalosis

Toxic encephalopathy

Venous thrombosis

100%

80%

60%

40%

20%

Study treatment Arm

Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase

Cetuximab + Cisplatin + 5-FU : Late Phase

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 11Eligibility criteria met

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.