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A Study of Erlotinib (Tarceva) in Participants With Resected Head and Neck Squamous Cell Cancer

This study has been terminated.
(The study was terminated because recruitment was too slow.)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00412217
First received: December 15, 2006
Last updated: October 11, 2016
Last verified: October 2016
  Purpose
This two-arm study will compare the efficacy and safety of erlotinib (Tarceva) versus placebo in participants with resected head and neck squamous cell cancer who are receiving concurrent chemoradiotherapy or radiotherapy alone. Participants will be randomized to receive either erlotinib 150 milligrams (mg) orally (PO) once daily or placebo for 1 year until disease progression or unacceptable toxicity.

Condition Intervention Phase
Head and Neck Cancer
Drug: Placebo
Drug: Erlotinib
Other: Standard of care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Randomized, Controlled Trial of Erlotinib (Tarceva) as Maintenance Therapy in Patients With Squamous Cell Carcinoma of the Head and Neck Treated With Resection and Radiotherapy With or Without Concomitant Chemotherapy With Curative Aim

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Number of Participants With Disease Progression [ Time Frame: From inclusion in the study until disease progression (maximum up to 3 years overall) ] [ Designated as safety issue: No ]
    Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The number of participants who experienced disease progression was reported.

  • Time to Progression (TTP) [ Time Frame: From inclusion in the study until disease progression, appearance of second tumor, or death from any cause (maximum up to 3 years overall) ] [ Designated as safety issue: No ]
    Tumor response was assessed by the Investigator according to standard-of-care criteria, as there were no protocol-specified criteria for the assessment of tumor response and the instrument for assessment was deferred to the Investigator. TTP was defined as the time from inclusion in the study to the time of disease progression, appearance of second tumor, or death from any cause, whichever occurred first. To ensure comparability, baseline radiological studies later used to verify progression must be performed using identical techniques. The median duration of TTP and corresponding 95% confidence interval (CI) were to be estimated by Kaplan-Meier analysis and expressed in months.


Secondary Outcome Measures:
  • Number of Participants Who Died [ Time Frame: From inclusion in the study until death from any cause (maximum up to 3 years overall) ] [ Designated as safety issue: No ]
    The number of participants who died from any cause was reported.

  • Overall Survival (OS) [ Time Frame: From inclusion in the study until death from any cause (maximum up to 3 years overall) ] [ Designated as safety issue: No ]
    OS was defined as the time from inclusion in the study to date of death for any reason. The median duration of OS and corresponding 95% CI were to be estimated by Kaplan-Meier analysis and expressed in months.


Enrollment: 94
Study Start Date: November 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Erlotinib
Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive erlotinib tablets as 150 mg PO daily for 1 year until disease progression or intolerable toxicity.
Drug: Erlotinib
Erlotinib will be given as 150 mg PO once daily.
Other Name: Tarceva
Other: Standard of care
Additional clinical management including surgical resection and chemoradiotherapy or radiotherapy alone will be at the discretion of the Investigator according to local standard of care.
Placebo Comparator: Placebo
Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive placebo treatment for 1 year until disease progression or intolerable toxicity.
Drug: Placebo
Participants will receive placebo tablets (matched to erlotinib) once daily.
Other: Standard of care
Additional clinical management including surgical resection and chemoradiotherapy or radiotherapy alone will be at the discretion of the Investigator according to local standard of care.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults greater than or equal to (≥) 18 years of age
  • Curatively treated head and neck squamous cell cancer with T3-T4 and/or N2-N3 pathology, with or without other findings of poor prognosis such as extranodal extension, positive resection margins, and perineural or vascular involvement
  • Eastern Cooperative Oncology Group (ECOG) status of 0 to 2

Exclusion Criteria:

  • Macroscopic residual disease after surgery
  • Previous treatment with anti-epidermal growth factor receptor (anti-EGFR) targeted therapies
  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: NCT00412217

Locations
Spain
Alcorcon, Spain, 28922
Barcelona, Spain, 08025
Barcelona, Spain, 08036
Barcelona, Spain, 08907
Barcelona, Spain, 08916
Burgos, Spain, 09005
Cordoba, Spain, 14004
Granada, Spain, 18014
Guadalajara, Spain, 19002
Jaen, Spain, 23007
Lugo, Spain, 27004
Madrid, Spain, 28006
Madrid, Spain, 28007
Madrid, Spain, 28033
Madrid, Spain, 28040
Madrid, Spain, 28041
Murcia, Spain, 30008
Orense, Spain, 32005
Palma de Mallorca, Spain, 07014
Salamanca, Spain, 37007
San Sebastian, Spain, 20012
San Sebastian, Spain, 20080
Santander, Spain, 39008
Sevilla, Spain, 41009
Sevilla, Spain, 41013
Toledo, Spain, 45004
Valencia, Spain, 41014
Valencia, Spain, 46015
Valencia, Spain, 46026
Zamora, Spain, 49021
Zaragoza, Spain, 50009
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00412217     History of Changes
Other Study ID Numbers: ML20294  2006-001845-33 
Study First Received: December 15, 2006
Results First Received: August 2, 2016
Last Updated: October 11, 2016
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 06, 2016