The purpose of this trial is to figure out what effects (good or bad) the investigational drug agent called Tarceva (erlotinib; OSI-774) has on women with previously untreated adenocarcinoma.
Patients will start taking Tarceva daily by mouth on Day 1 and will continue taking this medication daily at home, until participation in the study ends.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Overall Response Rate (ORR)
ORR is defined as the percentage of participants who achieve partial response (PR) or better on treatment based on RECIST 1.0 criteria: For target lesions, complete response (CR) is disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD (both require a minimum of 4 weeks). Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or appearance of one or more new target lesions. Stable disease (SD) is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions.
Time frame: In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.
Overall Response Rate (ORR) by EGFR Mutation Status
ORR is defined as the percentage of participants who achieve partial response (PR) or better on treatment based on RECIST 1.0 criteria: For target lesions, complete response (CR) is disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD (both require a minimum of 4 weeks). Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or appearance of one or more new target lesions. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions.
Time frame: In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.
Overall Survival (OS)
OS is defined as the time from study entry to death or date last known alive.
Time frame: In this study cohort, participants were followed for survival up to 155 months.
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Overall Survival by EGFR Mutation Status
OS is defined as the time from study entry to death or date last known alive.
Time frame: In this study cohort, participants were followed for survival up to 155 months.