Study of Chemotherapy Combined With Nimotuzumab in Untreated Metastatic Nasopharyngeal Carcinoma

Open-Label, Uncontrolled, Multicenter Phase II Study of Cisplatin and 5-Fu Combined With Nimotuzumab As First-Line Treatment in Patients With Untreated Metastatic Nasopharyngeal Carcinoma

This is an open-label, uncontrolled, multicenter phase II clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cisplatin and 5-Fu combined with nimotuzumab in patients with untreated metastatic nasopharyngeal carcinoma.

Study Overview

• Status: Completed
• Conditions: Stage IV Nasopharyngeal Carcinoma
• Intervention / Treatment: Drug: cisplatin and 5-Fu combined with nimotuzumab

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Cancer Center, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Histologic diagnosis of nasopharyngeal carcinoma
• Distance metastasis at least 6 months after radical treatment
• Not suitable for local treatment, e.g. surgery, TACE
• At least one measurable lesion
• Estimate survival >3months
• Range from 18～70 years old
• PS 0~1
• WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L
• ALT or AST < 2.5×ULN、bilirubin < 1.5×ULN
• 0Serum creatinine < 1.5×ULN

Exclusion Criteria:

• Central nervous system metastases
• Suitable for local treatment
• Second malignancy within 5 years
• Precious therapy with an investigational agent
• Uncontrolled seizure disorder or other serious neurologic disease
• ≥ Grade Ш allergic reaction to any drug including in this study
• Clinically significant cardiac or respiratory disease
• Creatinine clearance < 30ml/min
• Drug or alcohol addition
• Do not have full capacity for civil acts
• Severe complication, active infection
• Concurrent immunotherapy or hormone therapy for other diseases
• Pregnancy or lactation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF+ Nimotuzumab; Patients treated with cisplatin and 5-Fu combined with nimotuzumab	Drug: cisplatin and 5-Fu combined with nimotuzumab; DDP+5-Fu DDP 100 mg/m2 intravenous infusion in day1, 5-Fu 1000mg/m2/d continuous intravenous infusion on days 1 through 4, both drugs are given every 3 weeks. Nimotuzumab 200mg/d, intravenous infusion every week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate	To be determined by measurement of target lesions according to RECIST criteria	study period of 19 Months
Progression free survival	Defined as the time in months from first dose of Nimotuzumab until PD is observed or death occurs due to any cause.	19 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Defined as the time in months from first dose of Nimotuzumab to the date of death is observed or to last follow-up visit.	19 Months
Quality of life	Using EORTC QLQ-C30(version 3.0) and EORTC QLQ-H&N35(Version 1.0) to access the quality of life. Collecting data before treatment, 1 week after each 2 cycles of chemotherapy, 1 months after all treatment finished.	8 Months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Zhejiang Cancer Hospital; Guangxi Medical University; Wuhan University; Fujian Cancer Hospital; Tongji Hospital; Hubei Cancer Hospital; Jiangxi Provincial Cancer Hospital; Wuhan Union Hospital, China; Hangzhou Cancer Hospital; Affiliated Cancer Hospital of Shantou University Medical College; First People's Hospital of Foshan; People's Hospital of Guangxi; Guangzhou Medical University; Hunan Provincial Cancer Hospital

Publications and helpful links

General Publications

• Zhao C, Miao J, Shen G, Li J, Shi M, Zhang N, Hu G, Chen X, Hu X, Wu S, Chen J, Shao X, Wang L, Han F, Mai H, Chua MLK, Xie C. Anti-epidermal growth factor receptor (EGFR) monoclonal antibody combined with cisplatin and 5-fluorouracil in patients with metastatic nasopharyngeal carcinoma after radical radiotherapy: a multicentre, open-label, phase II clinical trial. Ann Oncol. 2019 Apr 1;30(4):637-643. doi: 10.1093/annonc/mdz020.

Helpful Links

• Home Page of Cancer Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: May 20, 2012
• First Submitted That Met QC Criteria: June 8, 2012
• First Posted (Estimate): June 12, 2012

Study Record Updates

• Last Update Posted (Estimate): September 22, 2015
• Last Update Submitted That Met QC Criteria: September 19, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Antineoplastic Agents; Antineoplastic Agents, Immunological; Nimotuzumab
• Other Study ID Numbers: PF-N-UMNPC