Ignite Creation Date:
2024-05-06 @ 12:55 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01691391
Status:
COMPLETED
Last Update Posted:
2020-11-04
First Post:
2012-05-15
Brief Title:
Early Biomarker With 18F-FDG PET for Treatment Optimization of Anti-EGFR Therapy in Patients With Metastatic Colorectal Cancer
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
Treatment Optimization of Anti-EGFR Therapy Cetuximab and Panitumumab in Patients With Metastatic Colorectal Cancer Based Early 18F-FDG-PET
Status:
COMPLETED
Status Verified Date:
2020-11
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:
3rd line standard treatment of patients with metastatic colorectal cancer CRC harboring K-ras wild type consists of anti-EGFR treatment with either cetuximab or panitumumab This type of treatment has a modest but significant beneficial activity in this patient group with improved progression-free and overall survival Although it is well known that patients with advanced CRC harboring a K-Ras mutation will not respond to anti-EGFR treatment it is not understood why patients with K-Ras wild type CRC do not all benefit from this type of therapy In order to optimize treatment of these patients as well as health care costs it is extremely important to identify those patients who will respond to treatment with an EGFR inhibitor at an early stage
The investigators hypothesize that the differences in response to treatment with cetuximab are due to variability in the pharmacokinetics and -dynamics of the antibody Thus the investigators hypothesize that patients who do not respond to anti-EGFR treatment have insufficient drug levels in tumor tissue The investigators hypothesize that this is due to pharmacodynamic processes such as sequestration of cetuximab in the liver which expresses high levels of EGF receptor
The phase I part of the study was fulfilled after inclusion of 36 patients to evaluate the potential applicability of the 89Zr-cetuximab PET as predictive marker for absence of response to cetuximab Along with this analysis FDG-PET evaluation before and after 1 administration of cetuximab was being performed While we observed no correlation of 89Zr-cetuximab tumor uptake with clinical benefit in these 36 patients we did find a clinical significant predictive value for the absence of response with early 18F-FDG-PET with the lack of clinical benefit at 2 months of treatment in this group of patients Early 18F-FDG PET response evaluation shows great potential to be a clinically applicable tool to stop an ineffective treatment in a very early phase after one administration of treatment Such an early predictor is unprecedented in clinical daily practice and will 1 avoid unnecessary toxicity of inactive treatment 2 will lead to faster prescription of a potentially active alternative treatment and 3 will reduce costs by preventing administration of inactive treatment In order to provide solid evidence for this new approach we aim to validate early 18F-FDG-PET as a predictive imaging strategy to identify non-responders in part 2 of the study
The investigators hypothesize that the differences in response to treatment with cetuximab are due to variability in the pharmacokinetics and -dynamics of the antibody Thus the investigators hypothesize that patients who do not respond to anti-EGFR treatment have insufficient drug levels in tumor tissue The investigators hypothesize that this is due to pharmacodynamic processes such as sequestration of cetuximab in the liver which expresses high levels of EGF receptor
The phase I part of the study was fulfilled after inclusion of 36 patients to evaluate the potential applicability of the 89Zr-cetuximab PET as predictive marker for absence of response to cetuximab Along with this analysis FDG-PET evaluation before and after 1 administration of cetuximab was being performed While we observed no correlation of 89Zr-cetuximab tumor uptake with clinical benefit in these 36 patients we did find a clinical significant predictive value for the absence of response with early 18F-FDG-PET with the lack of clinical benefit at 2 months of treatment in this group of patients Early 18F-FDG PET response evaluation shows great potential to be a clinically applicable tool to stop an ineffective treatment in a very early phase after one administration of treatment Such an early predictor is unprecedented in clinical daily practice and will 1 avoid unnecessary toxicity of inactive treatment 2 will lead to faster prescription of a potentially active alternative treatment and 3 will reduce costs by preventing administration of inactive treatment In order to provide solid evidence for this new approach we aim to validate early 18F-FDG-PET as a predictive imaging strategy to identify non-responders in part 2 of the study
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