Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma

University of Malaya

Status and phase: Terminated; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: Cetuximab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01230476

EMR 62202-832

Details and patient eligibility

About

Standard of care for treatment of nasopharyngeal carcinoma is chemoradiation with concurrent cisplatin. Addition of a second agent, cetuximab, which targets nasopharyngeal carcinoma cells with high EGFR protein expression, may enhance the effectiveness of radiation and result in better tumour control. This study investigates the addition of 2 cycles of cisplatin/5FU chemotherapy with cetuximab, followed by cisplatin and cetuximab concurrent with radiation, for treatment of locally advanced nasopharyngeal carcinoma.

Enrollment: 3 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed written informed consent
• Inpatients or outpatients, 18-65 years of age
• Histologically confirmed, newly diagnosed locally advanced (UICC/AJCC stage III to IVB) nasopharyngeal carcinoma requiring radiotherapy
• Evidence of unidimensional measurable disease as per RECIST criteria
• No systemic metastatic disease (M0)
• ECOG performance status of 0 or 1 at study entry
• Effective contraception
• White blood cell count ≥ 3,000/mm3 with neutrophils ≥1,500/mm3, platelet count ≥100,000/mm3, hemoglobin ≥ 5.6 mmol/L (9 g/dL)
• Total bilirubin ≤ 1.5x upper reference range
• AST & ALT ≤ 1.5x upper reference range
• Glomerular filtration rate > 60 ml/min
• Serum creatinine ≤ 1.25x upper reference range

Exclusion criteria

• Previous radiotherapy, chemotherapy, surgery (excluding diagnostic biopsy) or any investigational drug for the NPC
• Concurrent chronic systemic immune therapy, targeted therapy, anti-VEGF therapy or EGFR-pathway targeting therapy not indicated in this study protocol
• Known hypersensitivity reaction to any of the components of study treatments
• Pregnancy or lactation period
• Systemic metastatic disease
• Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
• Peripheral neuropathy > grade 1
• Previous malignancy except basal cell cancer of the skin or preinvasive cancer of the cervix
• Known alcohol or drug abuse
• Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent
• Legal incapacity or limited legal capacity

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Cetuximab and chemotherapy

Experimental group

Description:

2 cycles of neoadjuvant cisplatin and 5FU (3 weekly), given with weekly cetuximab, followed by 7 doses of weekly cisplatin and cetuximab concurrent with radiotherapy

Treatment:

Drug: Cetuximab