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

NCT ID: NCT01230476

Last Updated: 2019-10-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2015-05-31

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cetuximab and chemotherapy

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

Group Type: EXPERIMENTAL

Cetuximab

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Serono International SA

INDUSTRY

Sponsor Role: collaborator

University of Malaya

OTHER

Sponsor Role: lead

Responsible Party

Ho Gwo Fuang

Medical Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gwo Fuang Ho, FRCR

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Locations

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Countries

Malaysia

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

EMR 62202-832

Identifier Type: -

Identifier Source: org_study_id