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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01230476
Recruitment Status : Terminated
First Posted : October 29, 2010
Last Update Posted : October 7, 2019
Sponsor:
Collaborator:
Merck Serono International SA
Information provided by (Responsible Party):
Ho Gwo Fuang, University of Malaya

Tracking Information
First Submitted Date  ICMJE October 18, 2010
First Posted Date  ICMJE October 29, 2010
Last Update Posted Date October 7, 2019
Study Start Date  ICMJE May 2010
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2010)
Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01230476 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2010)
  • Objective response rate [ Time Frame: 1 year ]
    Assess the response rate of this combination treatment, as measured by imaging and endoscopy findings
  • Progression and overall survival [ Time Frame: 1 year ]
    To assess the PFS and OS at one year
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma
Official Title  ICMJE Induction and Concurrent Chemoradiotherapy With Cetuximab for Patients With Locally Advanced Nasopharyngeal Carcinoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nasopharyngeal Carcinoma
Intervention  ICMJE 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.
Study Arms  ICMJE 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
Intervention: Drug: Cetuximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 29, 2013)
3
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2010)
20
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01230476
Other Study ID Numbers  ICMJE EMR 62202-832
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ho Gwo Fuang, University of Malaya
Study Sponsor  ICMJE University of Malaya
Collaborators  ICMJE Merck Serono International SA
Investigators  ICMJE
Principal Investigator: Gwo Fuang Ho, FRCR University Malaya
PRS Account University of Malaya
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP