Skip to main content
OpenTrials
Completed

NCT Number: NCT01616849

Study of Chemotherapy Combined With Nimotuzumab in 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stage IV Nasopharyngeal Carcinoma Carcinoma Head and Neck Neoplasms Nasopharyngeal Carcinoma Nasopharyngeal Diseases Nasopharyngeal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cisplatin and 5-Fu combined with nimotuzumab

Drug

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

Primary outcomes

  1. Objective response rate

    Time frame: study period of 19 Months

    To be determined by measurement of target lesions according to RECIST criteria

  2. Progression free survival

    Time frame: 19 Months

    Defined as the time in months from first dose of Nimotuzumab until PD is observed or death occurs due to any cause.

Secondary outcomes

  1. Overall survival

    Time frame: 19 Months

    Defined as the time in months from first dose of Nimotuzumab to the date of death is observed or to last follow-up visit.

  2. Quality of life

    Time frame: 8 Months

    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.

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Collaborators

  • Affiliated Cancer Hospital of Shantou University Medical College
  • First People's Hospital of Foshan
  • Fujian Cancer Hospital
  • Guangxi Medical University
  • Guangzhou Medical University
  • Hangzhou Cancer Hospital
  • Hubei Cancer Hospital
  • Hunan Provincial Cancer Hospital
  • Jiangxi Provincial Cancer Hospital
  • People's Hospital of Guangxi Zhuang Autonomous Region
  • Tongji Hospital
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • Wuhan University
  • Zhejiang Cancer Hospital

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 12, 2012
Registry last updated
Sep 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.