Cetuximab for Chordoma

Overseen By Anthony Conley, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: EGFR inhibitors

Disqualifiers: Other invasive malignancy, uncontrolled hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

15 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) of at least 3 weeks from any systemic therapy (like small molecule/targeted agents or immunotherapies) and/or radiation therapy before starting the study. It does not specify about other medications, so you should discuss your current medications with the study team.

What evidence supports the effectiveness of the drug Cetuximab for treating chordoma?

Cetuximab has shown effectiveness in treating metastatic colorectal cancer by improving survival rates and reducing tumor size when used alone or in combination with other drugs. While this data is specific to colorectal cancer, it suggests that Cetuximab can be effective in targeting cancer cells by blocking the epidermal growth factor receptor, which is involved in the growth of many cancers. ^{1 2 3 4 5}

Is cetuximab generally safe for humans?

Cetuximab has been used in treating metastatic colorectal cancer and has shown some side effects like skin rash and nail infections, but severe side effects are rare. In studies, common side effects included skin issues and mild digestive problems, but it was generally well-tolerated by patients. ^{1 2 3 4 5}

How does the drug Cetuximab differ from other treatments for chordoma?

Cetuximab is unique because it is a monoclonal antibody that targets the epidermal growth factor receptor (EGFR), which is important in the growth of many cancers. While it is primarily used for metastatic colorectal cancer, its mechanism of action may offer a novel approach for treating chordoma, a condition with limited standard treatment options. ^{1 3 4 5 6}

What is the purpose of this trial?

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.

Research Team

Anthony P. Conley, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Negative serum pregnancy test for women of childbearing potential

Life expectancy of > 3 months

I can provide samples of my tumor for testing.

Exclusion Criteria

No measurable disease according to RECIST 1.1

History of allergic reactions to compounds similar to cetuximab, red meat allergy, or tick bite history

I have serious heart issues, including recent heart attacks or uncontrolled heart failure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cetuximab IV over 60-120 minutes weekly in the absence of disease progression or unacceptable toxicity

52 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cetuximab

Trial Overview 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.

Participant Groups

Group I: Treatment (cetuximab) Experimental Treatment 2 Interventions

Patients receive cetuximab IV over 60-120 minutes QW in the absence of disease progression or unacceptable toxicity.

Cetuximab is already approved in United States, European Union for the following indications:

Approved in United States as Erbitux for:

• Locally or regionally advanced squamous cell carcinoma of the head and neck
• Recurrent locoregional disease or metastatic squamous cell carcinoma of the head and neck
• K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer
• BRAF V600E mutation-positive metastatic colorectal cancer

Approved in European Union as Erbitux for:

• Squamous cell carcinoma of the head and neck
• K-Ras wild-type, EGFR-expressing, metastatic colorectal cancer

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Findings from Research

Cetuximab is a monoclonal antibody that targets the epidermal growth factor receptor, which plays a crucial role in the growth of various cancers.

It received accelerated approval from the US FDA in February 2004 for treating metastatic colorectal cancer based on positive tumor response rates observed in Phase II clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cetuximab. Goldberg, RM.[2020]

In a post-marketing surveillance study involving 2126 patients with metastatic colorectal cancer, cetuximab was found to be well tolerated, with a median treatment duration of 15.3 weeks and a high incidence of adverse reactions at 89.6%.

The most common adverse reactions included skin disorders (83.7%) and infusion reactions (5.7%), primarily occurring during the first administration, indicating that while side effects are common, they align with previous reports and suggest that cetuximab is clinically useful in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Japanese post-marketing surveillance of cetuximab (Erbitux®) in patients with metastatic colorectal cancer. Ishiguro, M., Watanabe, T., Yamaguchi, K., et al.[2022]

Cetuximab, a monoclonal antibody targeting the EGFR, has been approved for first-line treatment of KRAS mutation-negative metastatic colorectal cancer (mCRC) in combination with FOLFIRI, showing significant improvements in progression-free survival and overall survival.

The combination of cetuximab with FOLFIRI also resulted in higher objective response rates compared to FOLFIRI alone, making it a valuable treatment option for patients with EGFR-expressing, KRAS wild-type mCRC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cetuximab: a guide to its use in combination with FOLFIRI in the first-line treatment of metastatic colorectal cancer in the USA. Lyseng-Williamson, KA.[2021]

In a study of 8 patients with recurrent/advanced colorectal cancer, 6 patients showed a positive response to cetuximab, a targeted therapy that binds to epidermal growth factor receptors (EGFR), indicating its efficacy even in later lines of treatment.

Patients receiving cetuximab in combination with CPT-11 had significantly better progression-free survival (7.3 months) and time to treatment failure (9.3 months) compared to those on cetuximab monotherapy (3.0 months and 4.5 months, respectively), highlighting the potential benefits of combination therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The efficacy of cetuximab for metastatic colorectal cancer]. Katsumoto, Y., Aritake, N., Endoh, A.[2018]

In a study involving 65 patients with advanced colorectal cancer who had previously been treated with multiple therapies, the combination of cetuximab and irinotecan showed a response rate of 20% and a median overall survival of 10.4 months, confirming the efficacy of this treatment regimen.

The treatment was associated with low rates of severe toxicity, with only 8% experiencing grade 3 skin toxicity, indicating that cetuximab and irinotecan can be a safe option for heavily pretreated patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cetuximab and irinotecan as third line therapy in patients with advanced colorectal cancer after failure of irinotecan, oxaliplatin and 5-fluorouracil. Pfeiffer, P., Nielsen, D., Yilmaz, M., et al.[2018]

Cetuximab, when combined with irinotecan, can provide patients with metastatic colorectal cancer an additional 1.7 to 2.0 years of life, indicating its efficacy as a treatment option.

However, the cost-effectiveness analysis revealed that the treatment is quite expensive, with costs per life year gained ranging from 205,536 to 323,040 Euros, highlighting the financial considerations of using cetuximab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cetuximab in the treatment of metastatic colorectal cancer: a model-based cost-effectiveness analysis. Norum, J.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Cetuximab. [2020]

2. England pubmed.ncbi.nlm.nih.gov

A Japanese post-marketing surveillance of cetuximab (Erbitux®) in patients with metastatic colorectal cancer. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Cetuximab: a guide to its use in combination with FOLFIRI in the first-line treatment of metastatic colorectal cancer in the USA. [2021]

4. Japan pubmed.ncbi.nlm.nih.gov

[The efficacy of cetuximab for metastatic colorectal cancer]. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Cetuximab and irinotecan as third line therapy in patients with advanced colorectal cancer after failure of irinotecan, oxaliplatin and 5-fluorouracil. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Cetuximab in the treatment of metastatic colorectal cancer: a model-based cost-effectiveness analysis. [2019]