|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00585533 |
|
Date of registration:
|
26/12/2007 |
|
Primary sponsor: |
|
|
Public title:
|
A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer
|
|
Scientific title:
|
A Phase 2 Study of Tarceva for Untreated, Good Prognosis Patients With Advanced Non-Small Cell Lung Cancer |
|
Date of first enrolment:
|
June 2004 |
|
Target sample size:
|
40 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00585533 |
|
Study type:
|
Interventional |
|
Study design:
|
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Wallace Akerley, MD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of Utah |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Lung Cancer
|
|
Intervention(s)
|
|
Drug: Erlotinib (Tarceva)
|
|
Primary Outcome(s)
|
|
The study will be considered successful, if the 6-month chemotherapy-progression-free (CP-free) survival rate is significantly higher than the historically observed 31%. A one-sided binomial test at a 5% nominal significance will be used.
[Time Frame: June 2004-end]
|
|
Secondary Outcome(s)
|
|
Overall survival, (first) progression-free survival and CP-free survival will be estimated via a Kaplan-Meier curves. Survival will be counted from the first dose of Tarceva.
[Time Frame: June 2004-end]
|
|
Secondary ID(s)
|
|
HCI 12555
|
|
IRB# 00012555
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|