drugset / Trial / NCT01425736

Nimotuzumab in Combination With TPF(Cisplatin ,Fluorouracil and Docetaxel) for Head and Neck Squamous Cell Carcinoma

NCT01425736

Phase 2 Completed 91 enrolled Wei Guo Sun Yat-sen University · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2009-01
Primary completion
2011-01
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Nimotuzumab Monoclonal antibody 200 mg Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Docetaxel Small molecule 75 mg/m2 Intravenous
Background fluorouracil Small molecule 750 mg/m2