Nimotuzumab in Combination With TPF(Cisplatin ,Fluorouracil and Docetaxel) for Head and Neck Squamous Cell Carcinoma
Condition: Head and Neck Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Eligible patients were randomly assigned by using permutated blocks designed11 for each site
      to receive either Nimotuzumab combined with docetaxel-cisplatin-fluorouracil regimen (Arm A)
      or docetaxel-cisplatin-fluorouracil alone regimen (Arm B). Combination arm chemotherapy was
      as conducted as follows. Since day 1, Nimotuzumab (200 mg, given as a 2-hour intravenous
      infusion before chemotherapy, Biotech Pharmaceutical Inc., Beijing, China) was administrated
      1 h before chemotherapy once a week for two successive courses, followed by docetaxel (at a
      dose of 75 mg per square meter of body-surface area) was administered as a 1-hour intravenous
      infusion, followed by intravenous cisplatin (75 mg per square meter), administered during a
      period of 0.5 to 3 hours. After completion of the cisplatin infusion, fluorouracil (1000 mg
      per square meter per day) was administered as a continuous 24-hour infusion for 4 days.
      Patients in arm A received docetaxel-cisplatin-fluorouracil only.One treatment cycle
      comprised a period of 3 weeks (21 days). Patients received six cycles in both treatment arms,
      unless disease progression or unacceptable toxicity was observed. Patients in the
      experimental group who had at least stable disease could choose to continue maintenance
      Nimotuzumab every week until disease progression, intolerable toxicity, or study withdrawal.
    

Intervention name(s): Chemotherapy; Nimotuzumab and Chemotherapy
Intervention type(s): Drug; Drug
Intervention description(s): Chemotherapy :Docetaxel(75mg/m²,1 time/21d, 6times);Cisplatin(75mg/m²,1 time/21d, 6 times);Fluorouracil(750mg/m²/d,5times/21d, 30times); Nimotuzumab treatment:(200mg/w,18weeks );
Chemotherapy treatment:(Docetaxel(75mg/m²,1 time/21d, 6times);Cisplatin(75mg/m²,1 time/21d, 6 times);Fluorouracil(750mg/m²/d,5times/21d, 30times)Nimotuzumab treatment:(200mg/w,18weeks );
Other intervention name(s): Docetaxel; Cisplatin; Fluorouracil; Docetaxel; Cisplatin; Fluorouracil; Nimotuzumab
Intervention MeSH terms: Cisplatin; Docetaxel; Fluorouracil; Nimotuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nimotuzumab; Chemotherapy; Head and Neck Squamous Cell Carcinoma