Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137800
Status:
COMPLETED
Last Update Posted:
2020-04-03
First Post:
2005-08-29
Brief Title:
Study of OSI-774 Tarceva in Previously Untreated Elderly Lung Cancer Patients
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase II Study of OSI-774 Tarceva in Elderly Subjects With Previously Untreated Advanced Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this study is to determine whether the drug OSI-774 is less toxic and potentially as good as or better than standard chemotherapy drugs when given to subjects with non-small cell lung cancer who are 70 years of age or older
Detailed Description:
Patients will receive OSI-774 once daily without interruption There are no pre-determined number of cycles or planned dose interruptions For the purposes of evaluation toxicity and efficacy a four week 28 day period will be considered 1 cycle
Patients will continue to receive OSI-774 until they develop progressive disease unacceptable side-effects or wish to withdraw from the study
Patients will have radiographic evaluations after every two cycles of therapy After cycle 2 patients will also be evaluated by FDG-PET scanning
Patients will also be asked to fill out a Lung Cancer Symptom Scale LCSS on the first day of each cycle
Bloodwork will also be performed on day 1 of each cycle as well as at the end of the study
Patients will continue to receive OSI-774 until they develop progressive disease unacceptable side-effects or wish to withdraw from the study
Patients will have radiographic evaluations after every two cycles of therapy After cycle 2 patients will also be evaluated by FDG-PET scanning
Patients will also be asked to fill out a Lung Cancer Symptom Scale LCSS on the first day of each cycle
Bloodwork will also be performed on day 1 of each cycle as well as at the end of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None