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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well cetuximab works before surgery in treating aggressive skin cancer that has spread to nearby tissues or lymph nodes. Cetuximab, a monoclonal antibody, targets specific cells and may shrink tumors, reducing the amount of healthy tissue removed during surgery. Participants receive cetuximab through an IV once a week for eight weeks. The trial suits individuals with aggressive, untreated, or recurring skin cancer with large, deep tumors or tumors that have spread to nearby areas. Participants must agree to biopsies before and after treatment. As an unphased trial, this study provides a unique opportunity to enhance understanding of cetuximab's potential benefits before surgery.

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 prior data suggests that cetuximab is safe for treating skin cancer?

Research has shown that cetuximab is generally safe and well-tolerated. It has been used successfully in other cancers, such as colorectal cancer, to extend survival. Some studies have found that cetuximab can cause skin reactions, which are the most common side effects, including rash or dry skin. However, proper care usually manages these reactions. In skin cancer studies, cetuximab has proven effective and has not revealed any unexpected safety concerns. While side effects can occur, the treatment is considered safe for use in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Cetuximab is unique because it targets the epidermal growth factor receptor (EGFR), a protein that plays a critical role in the growth and survival of cancer cells. Unlike standard treatments for skin cancer, which often include surgery, radiation, or chemotherapy, cetuximab acts directly on this specific pathway, potentially offering a more targeted approach. Researchers are excited about cetuximab because it could provide an alternative for patients who do not respond well to conventional treatments, possibly improving outcomes by specifically disrupting cancer cell growth. Additionally, cetuximab is administered intravenously, allowing precise control over dosage and timing, which could enhance its effectiveness and reduce side effects.

What evidence suggests that cetuximab might be an effective treatment for skin cancer?

Research has shown that cetuximab, the treatment under study in this trial, can help treat certain types of skin cancer. In one study, 61% of patients using cetuximab did not see their cancer worsen after one year, and 40% after two years. Another study found that cetuximab had a 28% success rate in reducing cancer size, with 69% of patients seeing their cancer controlled after six weeks. These findings suggest that cetuximab can help manage fast-growing skin cancer and might be useful before surgery. Specifically, cetuximab could shrink tumors, possibly leading to less tissue needing removal during surgery. ^{6 7 8 9 10}

Who Is on the Research Team?

Adam Berger, MD

Principal Investigator

Rutgers Cancer Institute of New Jersey

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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 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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10327815/

Effectiveness and toxicity of cetuximab with concurrent RT ... Progression-free survival was 61% at 1 year and 40% at 2 years. With longer follow-up, some patients developed a local recurrence (16.7%), ...

2. oncotarget.com oncotarget.com/news/pr/cetuximabs-effectiveness-and-toxicity-in-advanced-cutaneous-squamous-cell-skin-cancer/

Cetuximab's Effectiveness and Toxicity in Advanced ... Progression-free survival was 61% at 1 year and 40% at 2 years. With longer follow-up, some patients developed a local recurrence (16.7%), ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.9562

Efficacy of cetuximab after immunotherapy (IO) in ... In prospective evaluation, the overall response rate (ORR) to cetuximab was 28% with disease control rate (DCR) of 69% at 6 weeks. The efficacy ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0959804925001601

Immunotherapy followed by cetuximab in locally advanced/ ... This study evaluates whether adding cetuximab to pembrolizumab can overcome resistance by reducing immune escape.

5. jnccn.org jnccn.org/view/journals/jnccn/21/3.5/article-pCLO23-068.xml

CLO23-068: Effectiveness and Toxicity of Cetuximab With ... Median progression-free survival was 21.6 months. Progression-free survival was 61% at 1 year and 40% at 2 years. With longer follow-up, 3 ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3228080/

Management of Skin Toxicity Associated with Cetuximab ... Cetuximab was demonstrated by clinical trials to improve response rate and survival of patients with metastatic and nonresectable colorectal cancer or carcinoma ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40632444/

The Role of Cetuximab in Non-Melanoma Skin Cancer This review evaluates the role of cetuximab in NMSC, focusing on clinical efficacy, safety, and emerging therapeutic strategies. A ...

8. oncotarget.com oncotarget.com/article/28470/text/

Effectiveness and toxicity of cetuximab with concurrent RT ... The median progression-free survival was 21.6 months, with a median follow-up of 18 months. A total of 60% of patients were progression free at ...

9. ecancer.org ecancer.org/en/news/23351-cetuximab-s-effectiveness-and-toxicity-in-advanced-cutaneous-squamous-cell-skin-cancer

Cetuximab's effectiveness and toxicity in advanced ... Progression-free survival was 61% at 1 year and 40% at 2 years. With longer follow-up, some patients developed a local recurrence (16.7%), ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S0959804925001601

Immunotherapy followed by cetuximab in locally advanced/ ... Cetuximab overcame pembrolizumab resistance, reaching a 63 % cumulative ORR. •. Cetuximab reversed primary/acquired resistance in 43 % of cSCC ...