Study of Chemotherapy Combined With Nimotuzumab in Untreated Metastatic Nasopharyngeal Carcinoma

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Affiliated Cancer Hospital of Shantou University Medical College; Cancer Hospital of Shantou University; First People's Hospital of Foshan; Fujian Cancer Hospital; Guangxi Medical University; Guangzhou Medical University; Hangzhou Cancer Hospital; Hubei Cancer Hospital; Hunan Provincial Cancer Hospital; Jiangxi Provincial Cancer Hospital; People's Hospital of Guangxi; Tongji Hospital; Wuhan Union Hospital, China; Wuhan University; Zhejiang Cancer Hospital
• Treatments: Cisplatin; Nimotuzumab

Criteria

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