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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial is testing a new drug to treat chordoma, a type of cancer. The target patient population is any chordoma patient 18 years of age with locally unresectable disease or metastatic disease.

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.Check my eligibility
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.See study design
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
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I am 18 years old or older.
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My chordoma cannot be removed by surgery and may have spread.
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I have at least one tumor that can be measured on scans.
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I can take care of myself but might not be able to do heavy physical work.
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I have never used EGFR inhibitors for my chordoma treatment.
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I am either postmenopausal, surgically sterile, or using effective birth control.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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%
Neutropenia
28%
Vomiting
26%
Decreased Appetite
22%
Pyrexia
19%
Acne
19%
Hyponatremia
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%
Hypochloremia
7%
Hypocalcaemia
7%
Dermatitis Acneiform
7%
Abdominal Pain Upper
7%
Paronychia
7%
Aspartate Aminotransferase Increased
7%
Weight Increased
6%
Oral Pain
6%
Neck pain
6%
Dyspnoea
6%
Headache
3%
Anaphylactic reaction
1%
Pulmonary embolism
1%
Pneumonitis
1%
Staphylococcal skin infection
1%
Respiratory alkalosis
1%
Tumor hemorrhage
1%
Electrolyte imbalance
1%
Microcytic anemia
1%
Mouth hemorrhage
1%
Myocardial infarction
1%
Pneumonia
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

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,349 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other experiments have been conducted utilizing Cetuximab?

"Presently, 122 Cetuximab studies are in progress with 30 trials at the third phase. Most of the clinical tests for this medication take place in Dresden, Arizona; however there are over 5500 other sites running such experiments."

Answered by AI

To what extent has participation been observed in this experiment?

"Affirmative. According to clinicaltrials.gov, this medical trial is currently in search of participants and was initially published on May 27th 2022. A total of 15 people are needed at one location for the study which has most recently been updated on June 1st 2022."

Answered by AI

Has the Food and Drug Administration authorized Cetuximab for public use yet?

"Cetuximab's safety has been supported to some extent, thus it was assigned a score of 2 on our scale. This is because this particular clinical trial is still in phase two and the efficacy hasn't been thoroughly demonstrated yet."

Answered by AI

Are participants eligible to join this experiment currently?

"According to the records on clinicaltrials.gov, this trial is actively seeking volunteers; it was initially posted in late May and updated at the start of June."

Answered by AI

What therapeutic benefits does Cetuximab typically provide?

"Cetuximab is widely prescribed as a pharmacotherapy for various medical conditions such as regionally advanced squamous cell carcinoma of the head and neck, metastatic hnscc, and general squamous cell carcinoma."

Answered by AI

Who else is applying?

What site did they apply to?
M D Anderson Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What state do they live in?
New York

What questions have other patients asked about this trial?

Do I have to pay for the treatment? How long will my treatment process take?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

How responsive is this trial?

Most responsive sites:
  1. M D Anderson Cancer Center: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email
~3 spots leftby Sep 2024