Lung Cancer
Conditions
Keywords
OSI-774, TARCEVA (ERLOTINIB), Lung, recurrent, 10-097, Gefitinib
Brief summary
The purpose of this study is to measure the ability of erlotinib to effectively treat recurrent lung cancer which carries an EGFR mutation lung cancer after prior treatment with erlotinib or gefitinib received in the post-surgical or post-radiation setting.
Interventions
DRUGerlotinib
After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A history of stage I-IIIB NSCLC * Previously underdone definitive surgery or radiation * Received prior adjuvant treatment or neoadjuvant with erlotinib or gefitinib for a total of at least 3 months at any time * Stopped adjuvant erlotinib or neoadjuvant at least 2 months prior to date of first imaging demonstrating recurrence * Pathologic evidence of recurrent lung cancer, confirmed at MSKCC EGFR sensitizing mutation (point mutation in exons 18 or 21, or deletion in exon 19) must be documented in the primary or recurrent tumor * Tissue from their recurrent tumor must be submitted for EGFR mutation testing, and to evaluate for the presence of the T790M mutation (results do not need to have been reported to be eligible) * Measurable disease by RECIST; if received prior irradiation, then must have a target lesion outside the irradiated field * Signed informed consent * Age \> or = to 21 years old * Persons of reproductive potential must agree to use an adequate method of contraception throughout treatment and for at least 4 weeks after study drug is stopped
Exclusion criteria
* Prior progressive disease while receiving erlotinib or gefitinib therapy * Patients with known pre-existing interstitial lung disease * Total bilirubin greater than 1.8 mg/dl, excepting patients known to have Gilbert's syndrome * AST or ALT greater than five times the upper limit of normal * Pregnant or lactating women * Medically unfit for erlotinib therapy as determined by treating oncologist
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Examine the Objective Response Rate (ORR) of Single-agent Erlotinib | 2 years | in recurrent EGFR-mutant lung cancer, given to patients who previously received adjuvant erlotinib or gefitinib |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Erlotinib This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.
erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST. | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Erlotinib |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
Primary
To Examine the Objective Response Rate (ORR) of Single-agent Erlotinib
in recurrent EGFR-mutant lung cancer, given to patients who previously received adjuvant erlotinib or gefitinib
Time frame: 2 years