Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Sun Yat-sen University
Information provided by (Responsible Party):
Wei Guo, Shanghai 9th People's Hospital Identifier:
First received: August 19, 2011
Last updated: June 1, 2014
Last verified: June 2014
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.

Condition Intervention Phase
Head and Neck Squamous Cell Carcinoma
Drug: Chemotherapy
Drug: Nimotuzumab and Chemotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Nimotuzumab in Combination With TPF for Head and Neck Squamous Cell Carcinoma

Resource links provided by NLM:

Further study details as provided by Shanghai 9th People's Hospital:

Primary Outcome Measures:
  • Rate of Disease Control (RDC) [ Time Frame: 4years ]

Secondary Outcome Measures:
  • toxicity, progression-free survival (PFS), and overall survival (OS). [ Time Frame: 4 years ]

Enrollment: 91
Study Start Date: January 2009
Study Completion Date: March 2013
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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
Chemotherapy :Docetaxel(75mg/m²,1 time/21d, 6times);Cisplatin(75mg/m²,1 time/21d, 6 times);Fluorouracil(750mg/m²/d,5times/21d, 30times)
Other Names:
  • Docetaxel
  • Cisplatin
  • Fluorouracil
Experimental: 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 ).

Drug: 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 );

Other Names:
  • Docetaxel
  • Cisplatin
  • Fluorouracil
  • Nimotuzumab

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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01425736

China, Guangdong
First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
China, Jiangsu
Institute of Stomatology of Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Wuxi People's Hospital; Nanjing Medical University
Wuxi, Jiangsu, China, 214000
Xuzhou Central Hospital of Xuzhou city,Dongnan University
Xuzhou, Jiangsu, China, 221009
China, Shanghai
9th People's Hospital, School of Stomatology,Shanghai Jiaotong University
Shanghai, Shanghai, China, 200011
Sponsors and Collaborators
Wei Guo
Sun Yat-sen University
Study Chair: Wei Guo, MD, PhD, DDS Dept. of Oral and Maxillofacial Surgery,9th People's Hospital, School of Stomatology,Shanghai Jiaotong University
  More Information

Responsible Party: Wei Guo, Guo Wei, Shanghai 9th People's Hospital., Shanghai 9th People's Hospital Identifier: NCT01425736     History of Changes
Other Study ID Numbers: BT-IST-SCCHN-008
Study First Received: August 19, 2011
Last Updated: June 1, 2014

Keywords provided by Shanghai 9th People's Hospital:
Head and Neck Squamous Cell Carcinoma

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators processed this record on May 25, 2017