Cetuximab Before Surgery in Treating Patients With Aggressive Locally Advanced Skin Cancer (NCT02324608) | Clinical Trial Compass
CompletedNot Applicable
Cetuximab Before Surgery in Treating Patients With Aggressive Locally Advanced Skin Cancer
United States15 participantsStarted 2015-01-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 =\< 2
* Estimated life expectancy of at least 12 weeks
* Negative pregnancy test
Exclusion Criteria:
* Second primary malignancy only if treatment would interfere with the patient's participation in this trial in the opinion of the treating physician; clear exceptions are 1) patient had a second primary malignancy but has been treated and disease free for at least 3 years, 2) in situ carcinoma (e.g. in situ carcinoma of the cervix) and, 3) additional skin cancers that have been definitively treated by surgery and/or radiation; patients with chronic lymphocytic leukemia will be allowed if their blood counts are within acceptable hematologic parameters and if they are not currently requiring cytotoxic or biologic anticancer treatment (supportive treatment such as intravenous immunoglobulin \[IVIG\] is permitted)
* Patients with distant organ metast…
What they're measuring
1
Response Rate of Cetuximab by RECIST Criteria
Timeframe: Up to 2 years
Trial details
NCT IDNCT02324608
SponsorRutgers, The State University of New Jersey