Study of Chemotherapy Combined With Nimotuzumab in Untreated Metastatic Nasopharyngeal Carcinoma

Phase 2

Completed

• Conditions: Stage IV Nasopharyngeal Carcinoma
• Interventions: Drug: cisplatin and 5-Fu combined with nimotuzumab

• Registration Number: NCT01616849
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-20
• Study First Submitted QC: 2012-06-08
• Study First Posted: 2012-06-12
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-19
• Last Update Posted: 2015-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PF+ Nimotuzumab	cisplatin and 5-Fu combined with nimotuzumab	Patients treated with cisplatin and 5-Fu combined with nimotuzumab

Primary Outcome Measures

Name	Time	Method
Objective response rate	study period of 19 Months	To be determined by measurement of target lesions according to RECIST criteria
Progression free survival	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 Outcome Measures

Name	Time	Method
Overall survival	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.
Quality of life	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.

Trial Locations

Locations (1)

Cancer Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China