N/A
N=15
Cetuximab Before Surgery in Treating Patients With Aggressive Locally Advanced Skin Cancer
Recurrent Skin Cancer · Squamous Cell Carcinoma of the Skin
Bottom Line
View on ClinicalTrials.gov: NCT02324608 ↗Enrolled (actual)
15
Serious AEs
13.3%
Results posted
Dec 2023
Primary outcome: Primary: Response Rate of Cetuximab by RECIST Criteria — 15 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- cetuximab (Biological); laboratory biomarker analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rutgers, The State University of New Jersey
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate of Cetuximab by RECIST Criteria |
15 | — |
| SECONDARY Progression-free Survival |
4 | — |
| SECONDARY Overall Survival |
8 | — |
| SECONDARY Downstream Activation of Signaling Pathways Without a Known Driver, Including the EGFRpathway |
— | — |
| SECONDARY Potential Markers of Response and/or Resistance to Cetuximab Therapy |
— | — |
Summary
This pilot clinical trial studies the side effects and how well cetuximab before surgery works in treating patients with skin cancer that forms, grows, and spreads quickly and has spread from where it started to nearby tissue or lymph nodes. Monoclonal antibodies, such as cetuximab, may block tumor growth in different ways be targeting certain cells. Giving cetuximab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Eligibility Criteria
Inclusion Criteria
- Patients must have untreated or relapsed SCCS that is considered to be aggressive and locally advanced by the following criteria: tumors 2 cm or more, tumors invading deep tissues such as muscle, cartilage or bone; tumors showing perineural invasion, and/or tumors metastatic to loco-regional lymph nodes; patients may have had prior surgical interventions or been treated with investigational agents with residual or recurrent disease
- Patients must give informed consent
- Patients must agree to pre- and post-treatment biopsies
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status = 12.5 mg/dl (> 3.1 mmol/L) despite intervention to normalize levels
- Magnesium 3 mg/dl (> 1.23 mmol/L) despite intervention to normalize levels
- Potassium 6 mmol/L despite intervention to normalize levels
- Prior radiation therapy is not an exclusion however, patient must have documented progression at the radiation site
Data sourced from ClinicalTrials.gov (NCT02324608). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.