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

Sponsor
Hoffmann-La Roche
Study ID
NCT00412217
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Placebo — DRUG
    Participants will receive placebo tablets (matched to erlotinib) once daily.
  • Erlotinib — DRUG
    Erlotinib will be given as 150 mg PO once daily.
  • 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.

Study Details

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.

Key Dates

Start date
Nov 30, 2006
Status verified
Oct 2016
Primary completion
Dec 31, 2009
Completion
Dec 31, 2009

Study Design

Enrollment
94 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Number of Participants With Disease Progression [ Time Frame: From inclusion in the study until disease progression (maximum up to 3 years overall) ]

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