Adenocarcinoma, Non-small Cell Lung Cancer
Conditions
Keywords
Tarceva, Erlotinib, OSI-774, Adenocarcinoma, Advanced Lung Cancer
Brief summary
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.
Detailed description
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.
Interventions
DRUGErlotinib
Sponsors
Dana-Farber Cancer Institute
Massachusetts General Hospital
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center
Genentech, Inc.
Pasi A. Janne, MD, PhD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female * Diagnosis of adenocarcinoma of the lung * Patient has had at least one core biopsy of her tumor * Must be willing to undergo epidermal growth factor receptor (EGFR) mutation testing of her tumor * Stage four (IV) or three (III) B non-small cell lung cancer * Non-smoker or former smoker. Non-smoker is defined as a person who smoked 100 or less cigarettes in her lifetime while a former smoker is defined as a person who has quit smoking one or more years ago. * Three or more weeks since last radiation therapy * Three or more weeks since last major surgery * Must at least be able to walk and capable of taking care of herself although unable to carry out work activities * Life expectancy of 8 weeks or more * Blood tests that show kidneys, liver and bone marrow to be working adequately * Women of child-bearing potential must agree to use adequate contraception prior to study entry and for the entire time enrolled in study
Exclusion criteria
* Prior exposure to Tarceva (OSI-774, erlotinib) * Uncontrolled central nervous system problems * Prior chemotherapy regimen * Difficulty swallowing * A disease or disorder that interferes with ability to digest and absorb food * Incomplete healing of previous oncologic or other major surgery * Significant medical history or unstable medical condition such as heart failure, active infection, uncontrolled high blood pressure * Pregnant or breast feeding * A medical condition that could make it unsafe for patient to participate in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) by EGFR Mutation Status | In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. | 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. |
| Overall Survival (OS) | In this study cohort, participants were followed for survival up to 155 months. | OS is defined as the time from study entry to death or date last known alive. |
| Overall Survival by EGFR Mutation Status | In this study cohort, participants were followed for survival up to 155 months. | OS is defined as the time from study entry to death or date last known alive. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled November 2004 to November 2008.
Participants by arm
| Arm | Count |
|---|---|
| Erlotinib Erlotinib: 150 mg orally once daily without interruption Cycle duration considered 4 weeks and treatment duration indefinite until disease progression, unacceptable toxicity or withdrawal for other reasons. | 84 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 7 |
| Overall Study | Death | 8 |
| Overall Study | Disease Progression | 60 |
| Overall Study | Not Start Treatment | 1 |
| Overall Study | Physician Decision | 7 |
| Overall Study | Prolonged Treatment Delay | 1 |
Baseline characteristics
| Characteristic | Erlotinib |
|---|---|
| Age, Continuous | 65 years |
| EGFR Status Mutant | 39 Participants |
| EGFR Status Unevaluable | 9 Participants |
| EGFR Status Wild Type | 36 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 78 Participants |
| Region of Enrollment United States | 84 participants |
| Sex: Female, Male Female | 84 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 83 / 84 |
| other Total, other adverse events | 83 / 83 |
| serious Total, serious adverse events | 33 / 83 |
Outcome results
Primary
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.
Population: The analysis dataset is comprised of all treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erlotinib | Overall Response Rate (ORR) | 27.7 percentage of participants |
Secondary
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.
Population: The analysis dataset is comprised of all treated participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erlotinib | Overall Response Rate (ORR) by EGFR Mutation Status | 56.4 percentage of participants |
| EGFR Wild Type | Overall Response Rate (ORR) by EGFR Mutation Status | 2.9 percentage of participants |
| Unevaluable EGFR | Overall Response Rate (ORR) by EGFR Mutation Status | 0.0 percentage of participants |
Secondary
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.
Population: The analysis dataset is comprised of all treated participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Overall Survival by EGFR Mutation Status | 32.6 months |
| EGFR Wild Type | Overall Survival by EGFR Mutation Status | 9.9 months |
| Unevaluable EGFR | Overall Survival by EGFR Mutation Status | 15.7 months |
Secondary
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.
Population: The analysis dataset is comprised of all enrolled participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Overall Survival (OS) | 22.9 months |