Study of Cetuximab in Nasopharyngeal Carcinoma (NPC) With Chemoradiotherapy

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open, multicenter phase Ⅱ clinical trial on cetuximab (C225) combined with IMRT + concurrent chemotherapy of cisplatin in locoregionally advanced nasopharyngeal carcinoma.

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

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Cancer Hospital of Guizhou Province; Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Central South University; First Affiliated Hospital of Guangxi Medical University; Fudan University; Fujian Cancer Hospital; Sichuan Cancer Hospital and Research Institute
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

• Informed consent form signed prior to study entry

• Age between 18-69 years old

• Pathology approved to be nasopharyngeal carcinoma (types WHO Ⅱ-Ⅲ)

• Stage Ⅲ, Ⅳa, Ⅳb according to UICC (International Union Against Cancer) 2002 6th edition criteria

• Primary tumor measurable

• KPS score ≥80

• Expected life span ≥6 months

• Adequate bone marrow function: White Blood Cell≥4×109/L，Hemoglobin≥100g/L，Platelet≥100×109/L

• Adequate liver function: ALAT/ASAT<1.5 × upper limit of normal (ULN), bilirubin <1.5×ULN

• Adequate renal function: Creatinine Clearance < 1.5×ULN

Exclusion Criteria:

• Evidence of distant metastatic disease

• Surgical procedure of the primary tumor or lymph nodes (except diagnostic biopsy)

• Previous radiotherapy for the primary tumor or lymph nodes

• Previous exposure to epidermal growth factor-targeted therapy

• Prior chemotherapy or immunotherapy for the primary tumor

• Other previous malignancy within 5 years, except non-melanoma skin cancer or pre-invasive carcinoma of the cervix

• Any investigational agent prior to the 1st study medication

• Participation in another clinical study within the 30 days prior to Inclusion in this study.

• Peripheral neuropathy > grade 1

• Known grade 3 or 4 allergic reaction to any of the study treatment

• History of severe pulmonary or cardiac disease

• Creatinine Clearance < 30ml/min

• Know drug abuse / alcohol abuse

• Legal incapacity or limited legal capacity

• Active systemic infection

• Medical or psychiatric illness, which in the investigators' opinions, would not permit the subject to complete or fully and completely understand the risks and potential complications of the study

• Concurrent chronic systemic immune therapy or hormone therapy not indicated in the study protocol

• Pregnancy (confirmed by serum or urine β-HCG) or lactation period

• Severe intercurrent illness, e.g. uncontrolled hypertension, cardiac failure