A Pilot Study of Neoadjuvant Cetuximab in Advanced Squamous Cell Carcinomas of Skin (SCCS)

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A Pilot Study of Neoadjuvant Cetuximab in Advanced Squamous Cell Carcinomas of Skin (SCCS)

1.1 Primary Endpoint
The co-primary endpoints are to a) assess the response rate of cetuximab by RECIST criteria in patients with advanced SCCS and b) to assess whether neoadjuvant cetuximab given in this patient population is both safe and feasible.

1.2 Secondary Endpoint(s)
1.2.1 To measure the progression free and overall survival of patients with advanced SCCS who receive neoadjuvant cetuximab
1.2.3 To determine the conversion to resectability of patients treated with neoadjuvant cetuximab and capture changes in reconstructive options rendered possible by neoadjuvant treatment
1.2.3 Molecular correlates. All patients must have a biopsy of the locoregional disease (primary site or neck lymph nodes), and of the skin prior to therapy. Patients will also have tissue harvested at surgery that will be analyzed or a second post treatment biopsy if surgery is note feasible. Our goals in the molecular analysis are to explore the following possibilities:
-Analyze the relationship of known 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
-Measure the downstream activation of signaling pathways without a known driver, including the EGFR pathway
-Determine if tumor shrinkage with cetuximab is associated with increased apoptosis as evidenced by activated caspase-3, in pre- and post- treatment tumor tisuses
-Determine whether cetuximab results in increased ADCC in post-, compared with pre-treatment tumor tissues

Protocol Number: 091303
Phase: Pilot
Applicable Disease Sites: Other Skin
Drugs Involved: CETUXIMAB
Principal Investigator: Janice Mehnert
Research Nurse: Jennifer Bryan
Scope: Local
Therapies Involved: Chemotherapy single agent systemic
Participating Institutions: Rutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@cinj.rutgers.edu.


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