Phase II Study of Nimotuzumab in Combination With TPF for Head and Neck Squamous Cell Carcinoma
18 Years
75 Years
Both
Head and Neck Squamous Cell Carcinoma
Trial Information
Phase II Study of Nimotuzumab in Combination With TPF for 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.
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
Disease progression-free survival
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Wei Guo, MD, PhD, DDS
Investigator Role:
Study Chair
Investigator Affiliation:
Dept. of Oral and Maxillofacial Surgery,9th People's Hospital, School of Stomatology,Shanghai Jiaotong University
Authority:
China: Food and Drug Administration
Study ID:
BT-IST-SCCHN-008
NCT ID:
NCT01425736
Start Date:
January 2009
Completion Date:
December 2011
Related Keywords:
- Head and Neck Squamous Cell Carcinoma
- Nimotuzumab
- Chemotherapy
- Head and Neck Squamous Cell Carcinoma
- Carcinoma
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
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