Ignite Creation Date:
2024-05-06 @ 12:54 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03874026
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2019-02-26
Brief Title:
Study of FolfiriCetuximab in FcGammaRIIIa VV Stage IV Colorectal Cancer Patients
Sponsor:
National Cancer Institute Naples
Organization:
National Cancer Institute Naples
Study Overview
Official Title:
Cetuximab Irinotecan and Fluorouracile in fiRst-line Treatment of Immunologically-selected Advanced Colorectal Cancer Patients the CIFRA Study
Status:
RECRUITING
Status Verified Date:
2023-10
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:
CIFRA
Brief Summary:
Patients selection thorough the identification of predictive factors still represent a challenge in metastatic colorectal cancer mCRC Cetuximab Erbitux a chimeric monoclonal antibody binding to the Epidermal Growth Factor Receptor EGFR belongs to the Immunoglobulins Ig grade 1 subclass able to elicit both in vitro and in vivo the Antibody-Dependent Cell-mediated Cytotoxicity ADCC ADCC is the cytotoxic killing of antibody-coated target cells by immunologic effectors The effector cells express a receptor for the Fc portion of these antibodies FcγR genetic polymorphisms of FcγR modify the binding affinity with the Fc of IgG1 Immunoglobulins Gamma subclass 1 Interestingly the high-affinity FcγRIIIa FcγR type IIIa VV is associated with increased ADCC in vitro and in vivo Thus ADCC could partially account for cetuximab activity CIFRA is a single arm open-label phase II study assessing the activity of cetuximab in combination with irinotecan and fluorouracile in FcγRIIIa VV patients with KRAS Kirsten RAt Sarcoma NRAS Neuroblastoma Rat Sarcoma BRAF B-Rapidly Accelerated Fibrosarcoma wild type mCRC The study is designed with a two-stage Simon model based on a hypothetical higher response rate 10 of FcγRIIIa VV patients as compared to previous trials about 60 assuming ADCC as one of the mechanisms of cetuximab action The test power is 95 the alpha value of the I-type error is 5 With these assumptions the sample for passing the first stage is 14 patients with 6 responses and the final sample is 34 patients with 18 responses to draw positive conclusions Secondary objectives include toxicity responses duration progression-free and overall survival Furthermore an associated translational study will assess the patients cetuximab-mediated ADCC and characterize the tumor microenvironment
The CIFRA study will determine whether ADCC contributes to cetuximab activity in mCRC patients selected on an innovative immunological screening Data from the translational study will support resultsinterpretation as well as provide new insights in host-tumor interactions and cetuximab activity
The CIFRA study will determine whether ADCC contributes to cetuximab activity in mCRC patients selected on an innovative immunological screening Data from the translational study will support resultsinterpretation as well as provide new insights in host-tumor interactions and cetuximab activity
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None