Ignite Creation Date:
2024-05-06 @ 3:33 AM
Last Modification Date:
2024-10-26 @ 11:35 AM
Study NCT ID:
NCT02316496
Status:
TERMINATED
Last Update Posted:
2017-08-01
First Post:
2014-12-08
Brief Title:
Rechallenge of Cetuximab Combined With Irinotecan as Third-line Chemotherapy in Patients With Metastatic Colorectal Cancer - Phase II Study
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
GERCOR - Multidisciplinary Oncology Cooperative Group
Study Overview
Official Title:
A Phase II Study of Cetuximab Rechallenge in Combination With Irinotecan in Advanced Metastatic Colorectal Cancer Without KRAS or NRAS or BRAF Mutation All Wild Type for Patients Pretreated With FOLFIRI and Cetuximab in First Line With Stopping Cetuximab for Progressive Disease After a Previous Response Partial Response or Complete Response and After Treatment With a Fluoropyrimidine Oxaliplatin Plus Bevacizumab Regimen
Status:
TERMINATED
Status Verified Date:
2017-01
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:
REGAIN
Brief Summary:
The main objective of this study is to evaluate the objective response rate at two months complete disappearance of the disease and partial disappearance of the disease obtained after administration of combination therapy with cetuximab and irinotecan in the patients with metastatic colorectal cancer
Secondaries objectives will be assessed progression-free survival overall survival toxicity quality of life
Secondaries objectives will be assessed progression-free survival overall survival toxicity quality of life
Detailed Description:
None
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