Phase II Study of RADPLAT and Tarceva in Locally Advanced Head and Neck Squamous Cell Carcinoma (SCCA)
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).
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Change in largest diameter of tumor lesion using RECIST criteria
17 weeks
Yes
Krishna Rao, MD, PhD
Principal Investigator
SIU School of Medicine
United States: Institutional Review Board
RAO-OSI-3601S
NCT00304278
March 2006
August 2012
Name | Location |
---|---|
Simmons Cooper Cancer Institute/SIU School of Medicine | Springfield, Illinois 62702 |