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

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01230476
• Other study ID #: EMR 62202-832
• Status: Terminated
• Phase: Phase 2
• Start date: May 2010
• Est. completion date: May 2015

Study information

• Verified date: October 2019
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 2015
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Drug:
• Cetuximab
Cetuximab loading dose of 400mg/m2, then weekly dose of 250mg/m2 for 12 doses; Neoadjuvant Cisplatin 75mg/m2 D1, 5FU 1000mg/m2 D2-5, for 2 cycles; Concurrent Cisplatin 30mg/m2 given with radiation 70Gy/35fraction/7weeks.

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Centre	Kuala Lumpur	Wilayah Persekutuan

Sponsors (2)

Lead Sponsor	Collaborator
University of Malaya	Merck Serono International SA

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events as a measure of safety and tolerability		1 year
Secondary	Objective response rate	Assess the response rate of this combination treatment, as measured by imaging and endoscopy findings	1 year
Secondary	Progression and overall survival	To assess the PFS and OS at one year	1 year