15 Participants Needed

Cetuximab for Skin Cancer

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Rutgers, The State University of New Jersey
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

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.12345

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.12367

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.12368

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

AB

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.
See 3 more

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.
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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
1Treatment groups
Experimental Treatment
Group I: Treatment (cetuximab)Experimental Treatment2 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

Find a Clinic Near You

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.
[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.
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.
Cetuximab.Goldberg, RM.[2020]

References

[The efficacy of cetuximab for metastatic colorectal cancer]. [2018]
Cutaneous squamous cell carcinoma responding serially to single-agent cetuximab. [2022]
Cetuximab. [2020]
[Topical application of EGF for the therapy of persisting corneal erosion under cetuximab treatment]. [2021]
Cetuximab and irinotecan as third line therapy in patients with advanced colorectal cancer after failure of irinotecan, oxaliplatin and 5-fluorouracil. [2018]
A Japanese post-marketing surveillance of cetuximab (Erbitux®) in patients with metastatic colorectal cancer. [2022]
Cetuximab: adverse event profile and recommendations for toxicity management. [2020]
Cetuximab: a guide to its use in combination with FOLFIRI in the first-line treatment of metastatic colorectal cancer in the USA. [2021]
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