Clinical trial NCT00412217: A Study of Erlotinib (Tarceva) in Participants With Resected Head and Neck Squamous Cell Cancer
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Head and Neck Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-12-18
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Number of Participants With Disease Progression
timeFrame: From inclusion in the study until disease progression (maximum up to 3 years overall)
measure: Time to Progression (TTP)
timeFrame: From inclusion in the study until disease progression, appearance of second tumor, or death from any cause (maximum up to 3 years overall)
Secondary outcomes:
measure: Number of Participants Who Died
timeFrame: From inclusion in the study until death from any cause (maximum up to 3 years overall)
measure: Overall Survival (OS)
timeFrame: From inclusion in the study until death from any cause (maximum up to 3 years overall)
Other outcomes:
Locations:
city: Alcorcon
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Burgos
country: Spain
city: Cordoba
country: Spain
city: Granada
country: Spain
city: Guadalajara
country: Spain
city: Jaen
country: Spain
city: Lugo
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Murcia
country: Spain
city: Orense
country: Spain
city: Palma de Mallorca
country: Spain
city: Salamanca
country: Spain
city: San Sebastian
country: Spain
city: San Sebastian
country: Spain
city: Santander
country: Spain
city: Sevilla
country: Spain
city: Sevilla
country: Spain
city: Toledo
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Zamora
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: