This will be the first prospective study where patients will be selected on the basis of two measures of the epidermal growth factor receptor (EGFR) pathway. The study will assess prospectively the efficacy of erlotinib as a single agent or intercalated with chemotherapy in highly selected patients with EGFR overexpression and/or EGFR amplification.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
143
6-month Progression-free Survival
Percentage of patients who's disease had not progressed at 6 months. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.
Time frame: 6 months after first dose
Progression-free Survival
Median time until disease progression. Disease progression defined as radiological and/or symptomatic disease progression or death in absence of progression.
Time frame: Until time of disease progression, as assessed every 21 days (maximum 28.8 months)
Overall Survival at 12 Months
Percentage of patients alive after 12 months of study treatment
Time frame: 12 months from 1st dose
Overall Survival
Median number of months from first study treatment until time of death
Time frame: From first study treatment until time of death (maximum 29.0 months)
Best Tumor Response
Change in size of tumor: Complete Response (CR) = no measurable tumor; Partial Response (PR) = 30% decrease in size of measurable tumor; Stable Disease (SD) = measurable tumor size has not changed; Progressive Disease (PD) = measurable tumor larger than at baseline
Time frame: While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months)
Duration of Tumor Response
Median length of time that tumor showed any type of response, ie, CR, PR, or SD
Time frame: While receiving study treatment; assessed every 21 days until progression (maximum 28.8 months).
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