Head and Neck Cancer Clinical Trial
Official title:
Phase II Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA)
The purpose of this study is to determine the safety and effectiveness of treatment with Tarceva (Erlotinib) and RADPLAT (RADiation and intraarterial cisPLATin) for patients with Head and Neck cancer
Head and neck malignancies represent a group of epidermoid tumors that arise from the
epithelial lining of the mouth, pharynx, and larynx. Three modalities of therapy have
established roles in the treatment of carcinoma of the head and neck: chemotherapy,
radiation therapy (XRT), and surgery. The choice of modality depends upon many factors such
as the site and extent of the primary lesion, the likelihood of complete surgical resection,
the presence of lymph node metastases, etc. Traditionally, smaller lesions (stage T1-T2) are
effectively treated either, by surgical excision or irradiation whereas more advanced
disease (stage III-IV) is treated with combined surgery and XRT. The subsequent morbidity
related to extensive surgery is a major problem among survivors. Clearly, there is a need to
develop therapeutic strategies for patients with advanced head and neck cancer with more
effective approaches employing non-surgical modalities.
Our hypothesis is that head and neck cancers are resistant to apoptosis from DNA damage
induced by radiation and chemotherapy. This resistance is mediated by EGFR overexpression
which results in downstream activation of cell survival signals, such as AKT, and may be
overcome when Erlotinib (Tarceva) is co-administered with RADiation and cisPLATin
(intraarterial chemotherapy).
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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