Lung Cancer
Conditions
Brief summary
This study will evaluate Tarceva in a selected population of patients with untreated advanced non-small cell lung cancer who are anticipated to have a relatively good (indolent) prognosis based on clinical criteria. It is anticipated that selection will enrich for tumor characteristic that are likely to be benefited by EGFR inhibitor treatment (survival greater than 90 days). The goal of this strategy is to provide a less toxic, oral treatment for patients with advanced NSCLC that will not interfere with patients receiving chemotherapy at some point in the future and may prolong the time to chemotherapy related progression. Patients will remain on study until disease progresses, a decline in performance status, if patient cannot tolerate the side effects or develops symptoms requiring conventional chemotherapy.
Detailed description
Primary Objective To determine Time to Chemotherapy Progression (ie includes time on Tarceva monotherapy and chemotherapy) in advanced NSCLC Secondary Objectives To evaluate survival and response rate associated with Tarceva treatment To study the frequency of symptom improvement (Lung Cancer Subscale)
Interventions
Erlotinib
Sponsors
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Performance status 0-1. * Weight Loss \< 10% in preceding 3 months * Age 18 years and older. * Adjuvant chemotherapy allowed if \> 6 months from protocol entry * Adequate Organ Function * Liver enzymes \< 2X normal, bilirubin = normal * Oxygen saturation\> 89% on room air unless chronically oxygen dependent (not cancer related) * Creatinine \<2.0 mg
Exclusion criteria
* Not pregnant or lactating. * No Clinical Brain Metastases * No prior chemotherapy for systemic disease * Imminent need for chemotherapy for impending organ dysfunction is not allowed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival Rate at 6-months Chemotherapy-progression-free (CP-free) | 6 months | Will determine if 6-month chemotherapy-progression-free (CP-free) survival rate (using RECIST) is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance was used. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | 24 months | Estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants enrolled in trial. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | objective or symptomatic progression | 9 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 30 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age Continuous | 65 years STANDARD_DEVIATION 10.09443 |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Survival Rate at 6-months Chemotherapy-progression-free (CP-free)
Will determine if 6-month chemotherapy-progression-free (CP-free) survival rate (using RECIST) is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance was used.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Participants | Survival Rate at 6-months Chemotherapy-progression-free (CP-free) | 55 percentage of participants |
Secondary
Overall Survival
Estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva.
Time frame: 24 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| All Participants | Overall Survival | 50.1 weeks |