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

This study is currently recruiting participants.

Verified by Hoffmann-La Roche, April 2009

First Received: December 15, 2006 Last Updated: April 15, 2009 History of Changes

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00412217

Purpose

This 2 arm study will compare the efficacy and safety of Tarceva, versus standard 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 anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Head and Neck Cancer	Drug: erlotinib Drug: Standard of care treatment	Phase III

MedlinePlus related topics: Cancer Head and Neck Cancer Radiation Therapy

Drug Information available for: Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

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 ]

Estimated Enrollment:	300
Study Start Date:	November 2006
Estimated Study Completion Date:	May 2012

Arms	Assigned Interventions
1: Experimental	Drug: erlotinib 150mg po daily
2: Active Comparator	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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412217

Contacts

Contact: Please reference Study ID Number: ML20294	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Locations

Spain
	Recruiting
SALAMANCA, Spain, 37007
	Recruiting
SANTANDER, Spain, 39008
	Recruiting
VALENCIA, Spain, 46015
	Recruiting
BARCELONA, Spain, 08907
	Recruiting
BURGOS, Spain, 09005
	Recruiting
Barcelona, Spain, 08036
	Recruiting
SAN SEBASTIAN, Spain, 20012
	Recruiting
VALENCIA, Spain, 41014
	Recruiting
VALENCIA, Spain, 46009
	Recruiting
ZARAGOZA, Spain, 50009
	Recruiting
Alcorcon, Spain, 28922
	Recruiting
MADRID, Spain, 28040
	Recruiting
MADRID, Spain, 28041
	Recruiting
MADRID, Spain, 28002
	Recruiting
GRANADA, Spain, 18014
	Recruiting
Barcelona, Spain, 08025
	Recruiting
SEVILLA, Spain, 41071
	Recruiting
CÓRDOBA, Spain, 14004
	Recruiting
MADRID, Spain, 28033
	Recruiting
MURCIA, Spain, 30008
	Recruiting
LUGO, Spain, 27004
	Recruiting
SAN SEBASTIAN, Spain, 20080
	Recruiting
PALMA DE MALLORCA, Spain, 07014
	Recruiting
MADRID, Spain, 28007
	Recruiting
ZAMORA, Spain, 49021
	Recruiting
JAEN, Spain, 23007
	Recruiting
GUADALAJARA, Spain, 19002
	Recruiting
TOLEDO, Spain, 45004
	Recruiting
ORENSE, Spain, 32005
	Recruiting
BARCELONA, Spain, 08916
	Recruiting
SEVILLA, Spain, 41013

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	ML20294
Study First Received:	December 15, 2006
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00412217 History of Changes
Health Authority:	Spain: Ministry of Health

Study placed in the following topic categories:

Erlotinib
Head and Neck Neoplasms
Epidermoid Carcinoma
Disease Progression
Neoplasms, Squamous Cell

Squamous Cell Carcinoma
Carcinoma, Squamous Cell
Protein Kinase Inhibitors
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Erlotinib
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Carcinoma

Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Neoplasms, Squamous Cell
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009