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

NCT01425736 | Completed Phase 2 DMC

• 1 other identifier: BT-IST-SCCHN-008
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 5

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

Nimotuzumab; Chemotherapy; Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Rate of Disease Control (RDC)

  4years

Secondary Outcomes (1)

• toxicity, progression-free survival (PFS), and overall survival (OS).

  4 years

Study Arms (2)

Chemotherapy

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

Nimotuzumab and Chemotherapy

EXPERIMENTAL

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

Interventions

Chemotherapy DRUG

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

Also known as: Docetaxel, Cisplatin, Fluorouracil

Chemotherapy

Nimotuzumab and Chemotherapy DRUG

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 );

Also known as: Docetaxel, Cisplatin, Fluorouracil, Nimotuzumab

Nimotuzumab and Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wei Guo: lead
• Sun Yat-sen University: collaborator

Study Sites (5)

First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Institute of Stomatology of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

Wuxi People's Hospital; Nanjing Medical University

Wuxi, Jiangsu, 214000, China

Location

Xuzhou Central Hospital of Xuzhou city,Dongnan University

Xuzhou, Jiangsu, 221009, China

Location

9th People's Hospital, School of Stomatology,Shanghai Jiaotong University

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Drug Therapy; Docetaxel; Cisplatin; Fluorouracil; nimotuzumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Wei Guo, MD, PhD, DDS

  Dept. of Oral and Maxillofacial Surgery,9th People's Hospital, School of Stomatology,Shanghai Jiaotong University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Guo Wei, Shanghai 9th People's Hospital.

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: August 30, 2011
• Study Start: January 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: March 1, 2013
• Last Updated: June 3, 2014

Record last verified: 2014-06

Locations

CN (5)