Squamous Cell Carcinoma of the Head and Neck Clinical Trial
Official title:
Safety and Efficacy Evaluation of Radiation and Cetuximab Plus Intratumoral EGFR Antisense DNA Patients With Locally Advanced Head and Neck Squamous Cell Carcinoma
The Epidermal Growth Factor Receptor (EGFR) is highly expressed in SCCHN and its overexpression is associated with poor patient outcome. EGFR is a promising target of anticancer therapy. We have developed EGFR antisense DNA as a safe and potentially efficacious treatment for SCCHN as shown in a previous phase I study conducted at the University of Pittsburgh. Cetuximab (Erbitux or C225) is a chimerized EGFR monoclonal antibody that has produced positive results in a phase III trial in SCCHN when added to radiation therapy and was approved by the FDA for the treatment of locally advanced SCCHN. Radiation plus cetuximab is considered a standard treatment, especially for patients who are not good candidates for chemotherapy. In the current study, we plan to evaluate the addition of intratumoral EGFR antisense DNA (EGFR AS) to standard radiation with concurrent cetuximab in patients.
Subject population We will enroll patients with SCCHN who are suitable for intratumoral
injections of EGFR antisense. Please see eligibility criteria.
Treatment plan
EGFR AS will be administered by direct intratumoral injection using direct visualization,
endoscopy, or imaging-guidance (ultrasound) as clinically determined . Patients will receive
a total of up to 7 weekly intratumoral injections of EGFR antisense (or less if there is no
identifiable tumor) starting 2 weeks prior to radiation. Patients will receive standard
radiation 70 Gy/200 cGy/daily, 5 days/week,excluding weekends and holidays, with concurrent
cetuximab 250 mg/m2, after a loading dose of 400 mg/m2 2 weeks prior to starting radiation.
Statistical Design and Sample Size The study will be conducted in two-stages. In the first
stage, 11 patients with stage IVA-C or recurrent disease will be evaluated for safety. If
the regimen is deemed safe, a total of 31 patients with stage III or IVA-B, previously
untreated SCCHN will be enrolled in the second stage of the study.
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