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
Overview
- Phase
- Phase 3
- Intervention
- Erlotinib
- Conditions
- Head and Neck Cancer
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 94
- Primary Endpoint
- Number of Participants With Disease Progression
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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.
Investigators
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
Arms & Interventions
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.
Intervention: 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.
Intervention: Standard of care
Placebo
Participants treated with surgical resection and chemoradiotherapy or radiotherapy alone will receive placebo treatment for 1 year until disease progression or intolerable toxicity.
Intervention: 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.
Intervention: Standard of care
Outcomes
Primary Outcomes
Number of Participants With Disease Progression
Time Frame: 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)
Time Frame: 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 Outcomes
- 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))