Open-Label, Multicenter, Phase Ⅱ Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

Sun Yat-sen University1 site in 1 country48 target enrollmentOctober 15, 2018

ConditionsNasopharyngeal Carcinoma

InterventionsDocetaxel and Cisplatin and Nimotuzumab

DrugsDocetaxel and Cisplatin and Nimotuzumab

Overview

Phase: Phase 2
Intervention: Docetaxel and Cisplatin and Nimotuzumab
Conditions: Nasopharyngeal Carcinoma
Sponsor: Sun Yat-sen University
Enrollment: 48
Locations: 1
Primary Endpoint: overall response rate
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of docetaxel and cisplatin combined with Nimotuzumab in the treatment of recurrent and metastatic nasopharyngeal carcinoma

Registry

clinicaltrials.gov

Start Date

October 15, 2018

End Date

June 30, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Qingqing Cai

Chief physician

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•biopsy proved nasopharyngeal carcinoma;
•stage IVB according to the eighth edition American Joint Committee on Cancer/Union for International Cancer Control staging system, or recurrent disease beyond more than 6 months after curative chemotherapy and/or radiotherapy;
•18-70 years;
•without other malignancy;
•had at least one measurable disease;
•had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
•estimated life expectancy exceeding 3 months;
•adequate functions of the major organs.

Exclusion Criteria

•allergic to docetaxel or cisplatin or nimotuzumab;
•pregnant or lactating female;
•patients received other clinical trails within 3 months;
•had serious infections, comorbidities or vital organs dysfunction.

Arms & Interventions

Docetaxel and Cisplatin and Nimotuzumab

All eligible patients received intravenous nimotuzumab plus docetaxel and cisplatin every 3 weeks for a maximum of 6 cycles, or until disease progression, death, intolerable toxicity.

Intervention: Docetaxel and Cisplatin and Nimotuzumab

Outcomes

Primary Outcomes

overall response rate

Time Frame: up to 18 weeks

the proportion of patients achieved partial response (PR) and complete response (CR) according to RECIST v1.1

Secondary Outcomes

disease control rate(up to 18 weeks)
duration of response(From date of documented response until the date of progressive disease [PD] or death, whichever came first, assessed up to 12 months)
progression-free survival(From date of the enrollment until the date of the documented PD or death, whichever came first, assessed up to 12 months)
overall survival(From date of the enrollment until the date of the documented death, assessed up to 72 months)
adverse events(up to 18 weeks)