Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-01-13 @ 12:25 PM
Study NCT ID:
NCT02324608
Status:
COMPLETED
Last Update Posted:
2023-12-20
First Post:
2014-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cetuximab Before Surgery in Treating Patients With Aggressive Locally Advanced Skin Cancer
Sponsor:
Rutgers, The State University of New Jersey
Organization:
Study Overview
Official Title:
A Pilot Study of Neoadjuvant Cetuximab in Advanced Squamous Cell Carcinomas of Skin (SCCS)
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
PRIMARY OBJECTIVES:
I. To assess the response rate of cetuximab by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with advanced squamous cell carcinoma of skin (SCCS).
II. To assess whether neoadjuvant cetuximab given in this patient population is both safe and feasible.
SECONDARY OBJECTIVES:
I. To measure the progression free and overall survival of patients with advanced SCCS who receive neoadjuvant cetuximab.
II. To determine the conversion to resectability of patients treated with neoadjuvant cetuximab and capture changes in reconstructive options rendered possible by neoadjuvant treatment.
III. Analyze the relationship of known deoxyribonucleic acid (DNA) mutations in tumor per the FoundationOneTM genomic profile, and correlate to clinical endpoints such as clinical benefit and conversion to resectability to discover potential markers of response and/or resistance.
IV. Measure the downstream activation of signaling pathways without a known driver, including the epidermal growth factor receptor (EGFR) pathway.
V. Determine if tumor shrinkage with cetuximab is associated with increased apoptosis as evidenced by activated caspase-3, in pre- and post- treatment tumor tissues.
VI. Determine whether cetuximab results in increased antibody-dependent cell cytotoxicity (ADCC) in post-, compared with pre-treatment tumor tissues.
OUTLINE:
Patients receive cetuximab intravenously (IV) over 60-120 minutes once weekly for 8 weeks.
After completion of study treatment, patients are followed up every 3 months for 2 years.
I. To assess the response rate of cetuximab by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with advanced squamous cell carcinoma of skin (SCCS).
II. To assess whether neoadjuvant cetuximab given in this patient population is both safe and feasible.
SECONDARY OBJECTIVES:
I. To measure the progression free and overall survival of patients with advanced SCCS who receive neoadjuvant cetuximab.
II. To determine the conversion to resectability of patients treated with neoadjuvant cetuximab and capture changes in reconstructive options rendered possible by neoadjuvant treatment.
III. Analyze the relationship of known deoxyribonucleic acid (DNA) mutations in tumor per the FoundationOneTM genomic profile, and correlate to clinical endpoints such as clinical benefit and conversion to resectability to discover potential markers of response and/or resistance.
IV. Measure the downstream activation of signaling pathways without a known driver, including the epidermal growth factor receptor (EGFR) pathway.
V. Determine if tumor shrinkage with cetuximab is associated with increased apoptosis as evidenced by activated caspase-3, in pre- and post- treatment tumor tissues.
VI. Determine whether cetuximab results in increased antibody-dependent cell cytotoxicity (ADCC) in post-, compared with pre-treatment tumor tissues.
OUTLINE:
Patients receive cetuximab intravenously (IV) over 60-120 minutes once weekly for 8 weeks.
After completion of study treatment, patients are followed up every 3 months for 2 years.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2014-02027 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| Pro20140000555 | OTHER | Rutgers Cancer Institute of New Jersey | View | |
| P30CA072720 | NIH | None | https://reporter.nih.gov/quic… | View |