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

This study has been terminated.
(The study was terminated due to low enrollment.)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00412217
First received: December 15, 2006
Last updated: October 13, 2014
Last verified: October 2014
  Purpose

This 2 arm study will compare the efficacy and safety of Tarceva, versus standar d of care, in patients with resected head and neck squamous cell cancer who are receiving concurrent chemo-radiotherapy or radiotherapy alone. Patients will be randomized to receive either Tarceva 150mg po daily or standard of care. The ant icipated time on study treatment is until disease progression, and the target sa mple size is 100-500 individuals.


Condition Intervention Phase
Head and Neck Cancer
Drug: erlotinib [Tarceva]
Drug: Standard of care treatment
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: A Randomized, Open Label, Study of the Effect of Tarceva on Progression Free Survival When Given as Maintenance Treatment Following Concurrent Chemo-radiotherapy or Radiotherapy Alone in Patients With Resected Head and Neck Squamous Cell Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

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: 1 Drug: erlotinib [Tarceva]
150mg po daily
Other Name: Tarceva
Active Comparator: 2 Drug: Standard of care treatment
As prescribed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • high risk totally resected head and neck squamous cell cancer: T3-T4 or N2-N3;
  • ECOG <=2.

Exclusion Criteria:

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00412217     History of Changes
Other Study ID Numbers: ML20294
Study First Received: December 15, 2006
Last Updated: October 13, 2014
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Head and Neck Neoplasms
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Neoplasms by Site
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014