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

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01425736
• Other study ID #: BT-IST-SCCHN-008
• Status: Completed
• Phase: Phase 2
• First received: August 19, 2011
• Last updated: June 1, 2014
• Start date: January 2009
• Est. completion date: March 2013

Study information

• Verified date: June 2014
• Source: Shanghai 9th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: March 2013
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Head and Neck Squamous Cell Carcinoma

Intervention

Drug:
• Chemotherapy
Chemotherapy :Docetaxel(75mg/m²,1 time/21d, 6times);Cisplatin(75mg/m²,1 time/21d, 6 times);Fluorouracil(750mg/m²/d,5times/21d, 30times)
• Nimotuzumab and Chemotherapy
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 );

Locations

Country	Name	City	State
China	First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	Institute of Stomatology of Nanjing Medical University	Nanjing	Jiangsu
China	9th People's Hospital, School of Stomatology,Shanghai Jiaotong University	Shanghai	Shanghai
China	Wuxi People's Hospital; Nanjing Medical University	Wuxi	Jiangsu
China	Xuzhou Central Hospital of Xuzhou city,Dongnan University	Xuzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Wei Guo	Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Disease Control (RDC)		4years	No
Secondary	toxicity, progression-free survival (PFS), and overall survival (OS).		4 years	No