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: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wei Guo
• Collaborator: Sun Yat-sen University
• Treatments: Cisplatin; Docetaxel; Fluorouracil; Nimotuzumab

Criteria

Inclusion Criteria:

• Joined the study voluntary and signed informed consent form

• Age 18-75，both genders.

• Had histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck

• 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 within 6 month

• Pregnant or breast-feeding women

• History of serious allergic or allergy

• Patients with the history of Serious lung or head disease

• Other malignant tumor

• not primary tumor(except for primary tumor therapy>3months)