Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391586
Status:
TERMINATED
Last Update Posted:
2015-08-17
First Post:
2006-10-23
Brief Title:
Erlotinib and Standard Platinum-Based Chemotherapy for Newly Diagnosed Advanced Non-Small Cell Carcinoma of the Lung
Sponsor:
New Mexico Cancer Care Alliance
Organization:
New Mexico Cancer Care Alliance
Study Overview
Official Title:
INST 0601C A Non-Randomized Phase II Protocol of Erlotinib for Patients With Newly Diagnosed Advanced Non-Small Cell Carcinoma of the Lung
Status:
TERMINATED
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was conducted to compare the activities of erlotinib to that of intravenous platinum-based therapy in the treatment of non-small cell lung cancer NSCLC The goal of this trial was to demonstrate clinical equivalence of erlotinib to platinum-based frontline therapy compared to historical controls
Detailed Description:
To compare the activities the progression-free survival the incidence and severity of toxicities and reversibility of toxicities of erlotinib to that of platinum-based therapy in NSCLC A sequential therapy design has been chosen such that all patients will receive any potential benefits of both platinum-based and erlotinib therapy without compromising survival by denying anyone potential therapy With this design progression-free survival will be tracked by treatment received However data will be generated which will show the safety and efficacy of erlotinib in the frontline setting alone and with historical comparison to platinum-based therapy as well as the potential safety and activity of platinum-based therapy in the second-line post-erlotinib setting This should allow for the demonstration of the relative median time to progression objective response and clinical benefit rates overall survival and safety and tolerability of erlotinib and platinum-based therapy in both the frontline and second-line settings in NSCLC Also in this fashion the treatments serve as controls for each other as well as being compared to historical controls in the first line treatment portion the platinum-based regimens serve as the historical control while in the second-line setting erlotinib serves as the historical control arm
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2012-01264 | REGISTRY | NCI CTRP | None |