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

Phase 2

Terminated

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Cetuximab

• Registration Number: NCT01230476
• Lead Sponsor: University of Malaya

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-10-18
• Study First Submitted QC: 2010-10-27
• Study First Posted: 2010-10-29
• Primary Completion: 2013-05
• Study Completion: 2015-05
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cetuximab and chemotherapy	Cetuximab	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

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events as a measure of safety and tolerability	1 year

Secondary Outcome Measures

Name	Time	Method
Objective response rate	1 year	Assess the response rate of this combination treatment, as measured by imaging and endoscopy findings
Progression and overall survival	1 year	To assess the PFS and OS at one year

Trial Locations

Locations (1)

University Malaya Medical Centre; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan, Malaysia