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

Primary Purpose

Nasopharyngeal Carcinoma

Status
Terminated
Phase
Phase 2
Locations
Malaysia
Study Type
Interventional
Intervention
Cetuximab
Sponsored by
University of Malaya
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring Locally advanced nasopharyngeal carcinoma, Neoadjuvant chemotherapy, Chemoradiation, Cetuximab

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Malaya Medical Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cetuximab and chemotherapy

Arm 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

Outcomes

Primary Outcome Measures

Number of participants with adverse events as a measure of safety and tolerability

Secondary Outcome Measures

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

Full Information

First Posted
October 18, 2010
Last Updated
October 2, 2019
Sponsor
University of Malaya
Collaborators
Merck Serono International SA
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1. Study Identification

Unique Protocol Identification Number
NCT01230476
Brief Title
Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma
Official Title
Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Study Start Date
May 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaya
Collaborators
Merck Serono International SA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
Locally advanced nasopharyngeal carcinoma, Neoadjuvant chemotherapy, Chemoradiation, Cetuximab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cetuximab and chemotherapy
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Cetuximab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with adverse events as a measure of safety and tolerability
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Objective response rate
Description
Assess the response rate of this combination treatment, as measured by imaging and endoscopy findings
Time Frame
1 year
Title
Progression and overall survival
Description
To assess the PFS and OS at one year
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gwo Fuang Ho, FRCR
Organizational Affiliation
University Malaya
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Malaya Medical Centre
City
Kuala Lumpur
State/Province
Wilayah Persekutuan
ZIP/Postal Code
59100
Country
Malaysia

12. IPD Sharing Statement

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

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