Phase II Study of Nimotuzumab in Combination With TPF for Head and Neck Squamous Cell Carcinoma
Eligible patients had advanced squamous cell carcinoma of the head and neck. Treatment
consisted of 3 cycles of docetaxel 75 mg per square meter, followed by intravenous
cisplatin 75 mg per square meter) and fluorouracil 750 mg per square meter per day,
administered as a continuous 24-h infusion for 4 days) with three cycles. Patients with
stable disease who received chemotherapy plus nimotuzumab continued to receive cetuximab
until disease progression or unacceptable toxic effects, whichever occurred first.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Disease progression-free survival
2 years
No
Wei Guo, MD, PhD, DDS
Study Chair
Dept. of Oral and Maxillofacial Surgery,9th People's Hospital, School of Stomatology,Shanghai Jiaotong University
China: Food and Drug Administration
BT-IST-SCCHN-008
NCT01425736
January 2009
December 2011
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