Back to resultsA Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer
Primary Purpose
Lung Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Erlotinib (Tarceva)
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer
Eligibility Criteria
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
Sites / Locations
- University of Utah
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall Survival
Estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00585533
Brief Title
A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer
Official Title
A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Erlotinib (Tarceva)
Other Intervention Name(s)
Tarceva
Intervention Description
Erlotinib
Primary Outcome Measure Information:
Title
Survival Rate at 6-months Chemotherapy-progression-free (CP-free)
Description
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
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wallace Akerley, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer
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