NCT01230476

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2010

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 29, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

October 7, 2019

Status Verified

October 1, 2019

Enrollment Period

3 years

First QC Date

October 18, 2010

Last Update Submit

October 2, 2019

Conditions

Nasopharyngeal Carcinoma

Keywords

Locally advanced nasopharyngeal carcinomaNeoadjuvant chemotherapyChemoradiationCetuximab

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (2)

  • Objective response rate

    1 year

  • Progression and overall survival

    1 year

Study Arms (1)

Cetuximab and chemotherapy

EXPERIMENTAL

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

Interventions

CetuximabDRUG

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.

Cetuximab and chemotherapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Gwo Fuang Ho, FRCR

    University of Malaya

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Lecturer

Study Record Dates

First Submitted

October 18, 2010

First Posted

October 29, 2010

Study Start

May 1, 2010

Primary Completion

May 1, 2013

Study Completion

May 1, 2015

Last Updated

October 7, 2019

Record last verified: 2019-10

Locations

MY(1)