Phase II Study to Evaluate Induction Chemotherapy Using Docetaxel, Cisplatin and Fluorouracil Followed by Weekly Docetaxel and Cetuximab in Concurrence With Intensity-modulated Radiotherapy for Locally Recurrent Nasopharyngeal Carcinoma (NPC)

Hong Kong Nasopharyngeal Cancer Study Group Limited4 sites in 1 country33 target enrollmentJune 2010

ConditionsNasopharyngeal Carcinoma

InterventionsDocetaxel, Cisplatin, 5-FU and Cetuximab

DrugsDocetaxel, Cisplatin, 5-FU and Cetuximab

Overview

Phase: Phase 2
Intervention: Docetaxel, Cisplatin, 5-FU and Cetuximab
Conditions: Nasopharyngeal Carcinoma
Sponsor: Hong Kong Nasopharyngeal Cancer Study Group Limited
Enrollment: 33
Locations: 4
Primary Endpoint: Complete response rate
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Study Objective:

Primary

To evaluate the complete response (CR) rate with induction chemotherapy using Docetaxel, Cisplatin and Fluorouracil(TPF) followed by Docetaxel plus Cetuximab (TC) in concurrence with intensity-modulated radiotherapy (IMRT).

Secondary

To determine the overall response rate.
To determine the locoregional and distant control rate
To determine the progression-free survival (PFS)
To determine the overall survival (OS)
To determine the safety of the induction chemotherapy and concurrent chemoradiation plus Cetuximab.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

March 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hong Kong Nasopharyngeal Cancer Study Group Limited

Responsible Party

Principal Investigator

Dr. ANNE W M LEE

Chief of Service, Dept of Clinical Oncology, PYNEH

Hong Kong Nasopharyngeal Cancer Study Group Limited

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•Use of investigational agent within the past 28 days
•Pre-treatment with an anti-EGFR drug
•Severe cardiac disease such as heart failure, coronary artery disease or myocardial infarction within the last 12 months
•History of severe pulmonary diseases
•Active infection or other systemic disease under poor control
•Uncontrolled chronic neuropathy
•Know grade 3 or 4 allergic reaction to any of the components of the treatment
•Estimated life expectancy is less than 3 months
•Pregnancy or breast feeding

Arms & Interventions

Experimental 1

Induction chemotherapy using Docetaxel, Cisplatin and 5-FU for week 1 to week 9 and followed by concurrent chemoradiation plus cetuximab from week 10 to week 16

Intervention: Docetaxel, Cisplatin, 5-FU and Cetuximab