Clinical trial NCT01425736: Nimotuzumab in Combination With TPF(Cisplatin ,Fluorouracil and Docetaxel) for Head and Neck Squamous Cell Carcinoma
Official title: Phase 2 Study of Nimotuzumab in Combination With TPF for Head and Neck Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: Nimotuzumab
Chemotherapy
Head and Neck Squamous Cell Carcinoma
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2011-08-30
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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)

Primary outcomes:
measure: Rate of Disease Control (RDC)
timeFrame: 4years
Secondary outcomes:
measure: toxicity, progression-free survival (PFS), and overall survival (OS).
timeFrame: 4 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Nanjing
country: China
facility: Institute of Stomatology of Nanjing Medical University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi People's Hospital; Nanjing Medical University
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Central Hospital of Xuzhou city,Dongnan University
state: Jiangsu
city: Shanghai
country: China
facility: 9th People's Hospital, School of Stomatology,Shanghai Jiaotong University
state: Shanghai
Study officials:
affiliation: Dept. of Oral and Maxillofacial Surgery,9th People's Hospital, School of Stomatology,Shanghai Jiaotong University
name: Wei Guo, MD, PhD, DDS
role: STUDY_CHAIR
References: