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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase 2 Study of Nimotuzumab in Combination With TPF for Head and Neck Squamous Cell Carcinoma

Conditions
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Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: Chemotherapy
* Drug: Nimotuzumab and Chemotherapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Chemotherapy<br>Chemotherapy :Docetaxel(75mg/m²,1 time/21d, 6times);Cisplatin(75mg/m²,1 time/21d, 6 times);Fluorouracil(750mg/m²/d,5times/21d, 30times) | Drug: Chemotherapy<br>* Chemotherapy :Docetaxel(75mg/m²,1 time/21d, 6times);Cisplatin(75mg/m²,1 time/21d, 6 times);Fluorouracil(750mg/m²/d,5times/21d, 30times)<br>* Other names: Fluorouracil;|
| Experimental: Nimotuzumab and Chemotherapy<br>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 ). | Drug: Nimotuzumab and Chemotherapy<br>* 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 );<br>* Other names: Nimotuzumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Disease Control (RDC) |  | 4years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity, progression-free survival (PFS), and overall survival (OS). |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nimotuzumab, Chemotherapy, Head and Neck Squamous Cell Carcinoma