Head and Neck Cancer
Conditions
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.
Interventions
DRUGPlacebo
Participants will receive placebo tablets (matched to erlotinib) once daily.
DRUGErlotinib
Erlotinib will be given as 150 mg PO once daily.
OTHERStandard of care
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.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erlotinib Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity. | 46 |
| Placebo Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity. | 48 |
| Total | 94 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 5 | 4 |
| Overall Study | Disease Progression | 2 | 3 |
| Overall Study | Insufficient Data Available | 8 | 3 |
| Overall Study | Investigator Decision | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 4 |
| Overall Study | Other | 1 | 1 |
| Overall Study | Study Terminated by Sponsor | 26 | 33 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Erlotinib | Placebo | Total |
|---|---|---|---|
| Age, Customized 18 Years or Older | 46 participants | 48 participants | 94 participants |
| Sex/Gender, Customized Female | 3 participants | 7 participants | 10 participants |
| Sex/Gender, Customized Male | 42 participants | 41 participants | 83 participants |
| Sex/Gender, Customized Unknown | 1 participants | 0 participants | 1 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 36 / 46 | 31 / 48 |
| serious Total, serious adverse events | 4 / 46 | 2 / 48 |
Outcome results
Primary
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.
Time frame: From inclusion in the study until disease progression (maximum up to 3 years overall)
Population: ITT Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erlotinib | Number of Participants With Disease Progression | 15 participants |
| Placebo | Number of Participants With Disease Progression | 11 participants |
Primary
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.
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)
Population: ITT Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Time to Progression (TTP) | NA months |
| Placebo | Time to Progression (TTP) | NA months |
Secondary
Number of Participants Who Died
The number of participants who died from any cause was reported.
Time frame: From inclusion in the study until death from any cause (maximum up to 3 years overall)
Population: ITT Population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erlotinib | Number of Participants Who Died | 7 participants |
| Placebo | Number of Participants Who Died | 5 participants |
Secondary
Overall Survival (OS)
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.
Time frame: From inclusion in the study until death from any cause (maximum up to 3 years overall)
Population: ITT Population.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Overall Survival (OS) | NA months |
| Placebo | Overall Survival (OS) | NA months |