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

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). Clinical efficacy has been shown in adult with head and neck cancer. The study assessed the overall survival(OS) and progress-free survival(PFS) of the combination of Nimotuzumab administered concomitantly with TPF in patients with 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.

• Drug: Chemotherapy
  Chemotherapy :Docetaxel(75mg/m²,1 time/21d, 3 times，on days 1,22,43);Cisplatin(75mg/m²,1 time/21d, 3 times，on day1,22,43); Fluorouracil 750mg/m²/d,5 times/21d, 15times)
  Other Names:

  • Docetaxel
  • Cisplatin
  • Fluorouracil
• Drug: Nimotuzumab and Chemotherapy

  Nimotuzumab treatment:(200mg/w,6weeks );

  Chemotherapy treatment:(Docetaxel(75mg/m²,1 time/21d, 3 times，on days 1,22,43);Cisplatin(75mg/m²,1 time/21d,3 times，on days 1,22,43);Fluorouracil (750mg/m²/d,5times/21d, 15times),Nimotuzumab treatment:(200mg/w,6weeks );

  Other Names:

  • Docetaxel
  • Cisplatin
  • Fluorouracil
  • Nimotuzumab

• Placebo Comparator: Chemotherapy

  Chemotherapy

  :Docetaxel(75mg/m²,1 time/21d, 3 times，on days 1,22,43);Cisplatin(75mg/m²,1 time/21d, 3 times，on days 1,22,43);Fluorouracil(750mg/m²/d,5times/21d, 15times)

  Intervention: Drug: Chemotherapy
• Experimental: Nimotuzumab and Chemotherapy

  Nimotuzumab treatment:(200mg/w,6weeks );

  Chemotherapy treatment:(Docetaxel(75mg/m²,1 time/21d, 3 times，on days 1,22,43);Cisplatin(75mg/m²,1 time/21d, 3 times，on days 1,22,43);Fluorouracil(750mg/m²/d,5times/21d, 15times),Nimotuzumab treatment:(200mg/w,6weeks ).

  Intervention: Drug: Nimotuzumab and Chemotherapy

Inclusion Criteria:

• Joined the study voluntary and signed informed consent form
• Age 18-75，both genders.
• oropharynx,pharynx,oral cavity carcinoma confirmed by pathology.
• Nasopharyngeal cancer 2008 Stages: III/IV.
• At least one lesions can be measured,Conventional measurements ≥2cm, computed tomography(CT) examination ≥1cm .
• Eastern Cooperative Oncology Group(ECOG) Performance Scale 0-2.
• Life expectancy of more than 3 months.
• Use of an effective contraceptive method for women when there is a risk of pregnancy during the study.
• Haemoglobin≥90g/L ,White blood cell(WBC) ≥3×10^9/L
• Hepatic function:ALAT、ASAT< 2.5 x ULN, TBIL< 1.5 x ULN
• Renal function: Creatinine < 1.5 x ULN

Exclusion Criteria:

• Received other anti EGFR monoclonal antibody treatment
• Participation in other interventional clinical trials within 1 month
• Previous received other drug or operative treatment
• Pregnant or breast-feeding women
• History of serious allergic or allergy
• Patients with the history of Serious lung or hear disease
• Other malignant tumor
• not primary tumor(except for primary tumor therapy>3months)