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

NCT00412217 | Terminated Phase 3 Results

• 2 other identifiers: ML202942006-001845-33
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 31

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.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Disease Progression

  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.

  From inclusion in the study until disease progression (maximum up to 3 years overall)

• Time to Progression (TTP)

  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.

  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 (2)

• Number of Participants Who Died

  From inclusion in the study until death from any cause (maximum up to 3 years overall)

• Overall Survival (OS)

  From inclusion in the study until death from any cause (maximum up to 3 years overall)

Study Arms (2)

Erlotinib

EXPERIMENTAL

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; Other: Standard of care

Placebo

PLACEBO COMPARATOR

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; Other: Standard of care

Interventions

Placebo DRUG

Participants will receive placebo tablets (matched to erlotinib) once daily.

Placebo

Erlotinib DRUG

Erlotinib will be given as 150 mg PO once daily.

Also known as: Tarceva

Erlotinib

Standard of care OTHER

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.

Erlotinib; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (31)

Unknown Facility

Alcorcón, 28922, Spain

Location

Unknown Facility

Barcelona, 08025, Spain

Location

Unknown Facility

Barcelona, 08036, Spain

Location

Unknown Facility

Barcelona, 08907, Spain

Location

Unknown Facility

Barcelona, 08916, Spain

Location

Unknown Facility

Burgos, 09005, Spain

Location

Unknown Facility

Córdoba, 14004, Spain

Location

Unknown Facility

Donostia / San Sebastian, 20012, Spain

Location

Unknown Facility

Donostia / San Sebastian, 20080, Spain

Location

Unknown Facility

Granada, 18014, Spain

Location

Unknown Facility

Guadalajara, 19002, Spain

Location

Unknown Facility

Jaén, 23007, Spain

Location

Unknown Facility

Lugo, 27004, Spain

Location

Unknown Facility

Madrid, 28006, Spain

Location

Unknown Facility

Madrid, 28007, Spain

Location

Unknown Facility

Madrid, 28033, Spain

Location

Unknown Facility

Madrid, 28040, Spain

Location

Unknown Facility

Madrid, 28041, Spain

Location

Unknown Facility

Murcia, 30008, Spain

Location

Unknown Facility

Ourense, 32005, Spain

Location

Unknown Facility

Palma de Mallorca, 07014, Spain

Location

Unknown Facility

Salamanca, 37007, Spain

Location

Unknown Facility

Santander, 39008, Spain

Location

Unknown Facility

Seville, 41009, Spain

Location

Unknown Facility

Seville, 41013, Spain

Location

Unknown Facility

Toledo, 45004, Spain

Location

Unknown Facility

Valencia, 41014, Spain

Location

Unknown Facility

Valencia, 46015, Spain

Location

Unknown Facility

Valencia, 46026, Spain

Location

Unknown Facility

Zamora, 49021, Spain

Location

Unknown Facility

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Erlotinib Hydrochloride; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

The Study was terminated early as a result of slow recruitment. Results should be interpreted with consideration of the small sample size.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2006
• First Posted: December 18, 2006
• Study Start: November 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: November 25, 2016
• Results First Posted: September 26, 2016

Record last verified: 2016-10

Locations

ES (31)