Cetuximab for Skin Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Distant metastases, Serious disorders, Allergic reactions, others

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

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

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

15 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the drug Cetuximab for skin cancer?

Cetuximab has shown effectiveness in treating a type of skin cancer called squamous cell carcinoma, especially in cases where the cancer cannot be surgically removed and has strong expression of a protein called EGFR (epidermal growth factor receptor). This suggests it may be beneficial for similar skin cancer cases. ^{1 2 3 4 5}

Is cetuximab generally safe for humans?

Cetuximab is generally considered safe for humans, but it can cause some side effects like skin rashes and nail problems. Severe allergic reactions during infusion are rare but can be serious, so medical staff usually take precautions to prevent them. Overall, its safety profile is favorable compared to many traditional chemotherapy drugs. ^{1 2 3 6 7}

How is the drug Cetuximab unique in treating skin cancer?

Cetuximab is unique for treating skin cancer because it specifically targets the epidermal growth factor receptor (EGFR), which is important for the growth of many cancers, and has shown repeated effectiveness in cases of nonresectable squamous cell skin cancer with strong EGFR expression, especially in a palliative setting where other treatments may not be effective. ^{1 2 3 6 8}

What is the purpose of this trial?

This trial studies how well cetuximab works in patients with aggressive skin cancer. Cetuximab targets and blocks a protein on cancer cells, stopping them from growing. The goal is to shrink the tumor and make surgery easier.

Research Team

Adam Berger, MD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Eligibility Criteria

This trial is for patients with aggressive, locally advanced skin cancer that hasn't spread to distant organs. Participants must be relatively fit (ECOG <=2), not pregnant, and willing to consent to treatment and biopsies. They should have a life expectancy of at least 12 weeks and cannot join if they have serious health issues, certain mineral imbalances, or allergies to cetuximab.

Inclusion Criteria

You must have a negative pregnancy test.

Patients must agree to pre- and post-treatment biopsies

Patients must have a performance status of 2 or lower according to the Eastern Cooperative Oncology Group (ECOG) scale.

Exclusion Criteria

Serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient's ability to complete the study

You had radiation therapy before, but your condition has gotten worse at the place where you had the radiation.

Your blood potassium levels are too low or too high, even after trying to fix them.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients receive cetuximab intravenously over 60-120 minutes once weekly for 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Every 3 months

Treatment Details

Interventions

• Cetuximab

Trial Overview The study tests the effects of cetuximab, a monoclonal antibody targeting cancer cells when given before surgery. The goal is to see if it can shrink tumors effectively enough to reduce the amount of normal tissue removed during surgery.

Participant Groups

Group I: Treatment (cetuximab) Experimental Treatment 2 Interventions

Patients receive cetuximab IV over 60-120 minutes once weekly for 8 weeks.

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?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Rutgers Cancer Institute of New Jersey

Collaborator

Trials

72

Recruited

22,200+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

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]

Cetuximab, a monoclonal antibody targeting the epidermal growth factor receptor, has shown repeated effectiveness in treating a patient with nonresectable squamous cell skin cancer, which is significant given the poor prognosis of advanced cases.

This case suggests that cetuximab could be a valuable treatment option for patients with squamous cell carcinomas that express the epidermal growth factor receptor, particularly in palliative care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cutaneous squamous cell carcinoma responding serially to single-agent cetuximab. Suen, JK., Bressler, L., Shord, SS., et al.[2022]

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]

Cetuximab, a treatment for advanced colorectal cancer, can lead to severe corneal erosion, as seen in a 62-year-old patient, despite ongoing conservative treatment.

Topical application of human EGF eye drops effectively promoted corneal healing, closing epithelial defects within 7 to 19 days, allowing continued cetuximab treatment and potentially preventing further complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Topical application of EGF for the therapy of persisting corneal erosion under cetuximab treatment]. Förster, CG., Cursiefen, C., Kruse, FE.[2021]

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]

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 is an effective monoclonal antibody that targets the epidermal growth factor receptor, which is linked to poor outcomes in solid tumors, by blocking its activation and associated oncogenic processes.

While cetuximab can cause infusion reactions and skin-related side effects, its overall safety profile is favorable compared to traditional chemotherapy, and these side effects are generally manageable with appropriate treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cetuximab: adverse event profile and recommendations for toxicity management. Thomas, M.[2020]

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]

References

1. Japan pubmed.ncbi.nlm.nih.gov

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

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

Cutaneous squamous cell carcinoma responding serially to single-agent cetuximab. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Cetuximab. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

[Topical application of EGF for the therapy of persisting corneal erosion under cetuximab treatment]. [2021]

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

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

7. United States pubmed.ncbi.nlm.nih.gov

Cetuximab: adverse event profile and recommendations for toxicity management. [2020]

8. 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]