Nimotuzumab in Combination With TPF(Cisplatin ,Fluorouracil and Docetaxel) for Head and Neck Squamous Cell Carcinoma
Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
Summary
Nimotuzumab (hR3) is an humanized monoclonal antibody that recognized an epitope located in
the extra cellular domain of the human epidermal growth factor receptor (EGFR). In phase II
clinical trials a combination of Nimotuzumab with chemotherapy or radiation therapy achieved
satisfactory therapeutic outcomes in patients with advanced squamous cell carcinoma of head
and neck, or glioblastoma. We therefore postulated that Nimotuzumab in combination with
conventional definitive chemotherapy might improve the rate of disease control (RDC),
progression-free survival (PFS),and overall survival in patients with recurrent and/or
metastatic SCCHN , which is a poor-prognosis patient population for whom there is currently
no standard treatment approach, we designed this trial to test this hypothesis.