Ignite Creation Date:
2024-05-05 @ 10:06 PM
Last Modification Date:
2024-10-26 @ 10:14 AM
Study NCT ID:
NCT01038037
Status:
TERMINATED
Last Update Posted:
2014-12-04
First Post:
2009-12-22
Brief Title:
First-Line Chemotherapy and Panitumumab in Advanced Non-Small Cell Lung Cancer
Sponsor:
Vejle Hospital
Organization:
Vejle Hospital
Study Overview
Official Title:
A Phase II Study of First-Line Chemotherapy and Panitumumab in Advanced NSCLC Selected by Mutational Status
Status:
TERMINATED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
1 Very low enrollment rate
2 Recent studies question the effect of adding panitumumab in this category of patients
3 Too high toxicity rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Lung-TRIO
Brief Summary:
The purpose of this study is to determine whether the addition of panitumumab to standard chemotherapy in first-line treatment of advanced Non Small Cell Lung Cancer improves the treatment outcome Patients are selected based on triple mutational status
Detailed Description:
Advanced NSCLC holds a very poor prognosis with a moderate response rate to standard chemotherapy The standard first-line treatment for advanced NSCLC is platinum based combination chemotherapy The response rates are less than 30 and a substantial amount of patients will experience unnecessary toxicity in terms of eg nausea vomiting neuropathies or a considerable risk of renal toxicity The median progression free survival is 3-4 months and consequently the median overall survival is less than one year Hotta et al 2007 Addition of new biological agents to standard chemotherapy regimens may improve the outcome for these patients
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