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

This study has been terminated.
Sponsor:
Collaborator:
Merck Serono International SA
Information provided by (Responsible Party):
Ho Gwo Fuang, University of Malaya
ClinicalTrials.gov Identifier:
NCT01230476
First received: October 18, 2010
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Nasopharyngeal Carcinoma
Drug: Cetuximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Malaya:

Primary Outcome Measures:
  • Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Objective response rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Assess the response rate of this combination treatment, as measured by imaging and endoscopy findings

  • Progression and overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    To assess the PFS and OS at one year


Enrollment: 3
Study Start Date: May 2010
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01230476

Locations
Malaysia
University Malaya Medical Centre
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
Sponsors and Collaborators
University of Malaya
Merck Serono International SA
Investigators
Principal Investigator: Gwo Fuang Ho, FRCR University Malaya
  More Information

No publications provided

Responsible Party: Ho Gwo Fuang, Medical Lecturer, University of Malaya
ClinicalTrials.gov Identifier: NCT01230476     History of Changes
Other Study ID Numbers: EMR 62202-832
Study First Received: October 18, 2010
Last Updated: May 29, 2013
Health Authority: Malaysia: Ministry of Health

Keywords provided by University of Malaya:
Locally advanced nasopharyngeal carcinoma
Neoadjuvant chemotherapy
Chemoradiation
Cetuximab

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Head and Neck Neoplasms
Nasopharyngeal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Otorhinolaryngologic Neoplasms
Pharyngeal Neoplasms
Carcinoma
Otorhinolaryngologic Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Cetuximab
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014