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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01616849

Enrollment

Registered

2012-06-12

Start date

2012-05-31

Completion date

2015-07-31

Last updated

2015-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage IV Nasopharyngeal Carcinoma

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.

Interventions

DRUGcisplatin 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026