A Study of Erlotinib (Tarceva) in Participants With Resected Head and Neck Squamous Cell Cancer
- Conditions
- Head and Neck Cancer
- Interventions
- Registration Number
- NCT00412217
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 94
- 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
- Macroscopic residual disease after surgery
- Previous treatment with anti-epidermal growth factor receptor (anti-EGFR) targeted therapies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Erlotinib Standard of care 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 Standard of care Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive placebo treatment for 1 year until disease progression or intolerable toxicity. Placebo Placebo Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive placebo treatment for 1 year until disease progression or intolerable toxicity. Erlotinib 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Disease Progression From inclusion in the study until disease progression (maximum up to 3 years overall) 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.
Time to Progression (TTP) From inclusion in the study until disease progression, appearance of second tumor, or death from any cause (maximum up to 3 years overall) 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.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Died From inclusion in the study until death from any cause (maximum up to 3 years overall) The number of participants who died from any cause was reported.
Overall Survival (OS) From inclusion in the study until death from any cause (maximum up to 3 years overall) OS was defined as the time from inclusion in the study to date of death for any reason. The median duration of OS and corresponding 95% CI were to be estimated by Kaplan-Meier analysis and expressed in months.