Study of Chemotherapy Combined With Nimotuzumab in Untreated Metastatic Nasopharyngeal Carcinoma

Sun Yat-sen University

Status and phase: Completed; Phase 2

Conditions: Stage IV Nasopharyngeal Carcinoma

Treatments: Drug: cisplatin and 5-Fu combined with nimotuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01616849

PF-N-UMNPC

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

PF+ Nimotuzumab

Experimental group

Description:

Patients treated with cisplatin and 5-Fu combined with nimotuzumab

Treatment:

Drug: cisplatin and 5-Fu combined with nimotuzumab