Status:
COMPLETED
Nimotuzumab in Combination With TPF(Cisplatin ,Fluorouracil and Docetaxel) for Head and Neck Squamous Cell Carcinoma
Lead Sponsor:
Wei Guo
Collaborating Sponsors:
Sun Yat-sen University
Conditions:
Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 ...
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-c...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT01425736
Start Date
January 1 2009
End Date
March 1 2013
Last Update
June 3 2014
Active Locations (5)
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1
First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
2
Institute of Stomatology of Nanjing Medical University
Nanjing, Jiangsu, China, 210000
3
Wuxi People's Hospital; Nanjing Medical University
Wuxi, Jiangsu, China, 214000
4
Xuzhou Central Hospital of Xuzhou city,Dongnan University
Xuzhou, Jiangsu, China, 221009