Trial of Aflibercept Monotherapy With DCE-US in Chemorefractory Metastatic Colorectal Cancer

Phase 2

Withdrawn

• Conditions: Colorectal Cancer
• Interventions: Drug: Aflibercept; Procedure: Dynamic Contrast Enhanced Ultrasound

• Registration Number: NCT03264274
• Lead Sponsor: Barts & The London NHS Trust

Brief Summary

Various antiangiogenic agents have a modest effect in prolonging overall survival in solid tumours. In colorectal cancer it is clear that there are some patients in whom bevacizumab significantly prolongs survival, but it is not effective in the majority of patients. Biomarker studies using tumour tissue and blood have failed to define a consistent biomarker that correlates with a beneficial effect of bevacizumab on survival. DCE-MRI can detect changes in tumour blood flow which, in early phase drug studies, correlated with subsequent tumour responses, but is too expensive and time consuming to be used in larger scale trials. DCE-US is a promising biomarker for use in this group of patients with antiangiogenic agents, as detailed above. The investigators wish to use this technique as a predictive biomarker for any effects Aflibercept has on OS and PFS in patients with metastatic colorectal cancer refractory to standard treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-31
• Study Start: 2017-02-06
• Primary Completion: 2017-02-06
• Study Completion: 2017-02-06
• Status Verified: 2017-08
• Study First Submitted QC: 2017-08-25
• Study First Posted: 2017-08-29
• Last Update Submitted: 2017-08-30
• Last Update Posted: 2017-08-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aflibercept + DCE-US	Aflibercept	Aflibercept: 4mg/kg IV every 2 weeks until discontinuation due to progression. DCE-US before treatment, and at 2 weeks and 8 weeks after the first Aflibercept administration.
Aflibercept + DCE-US	Dynamic Contrast Enhanced Ultrasound	Aflibercept: 4mg/kg IV every 2 weeks until discontinuation due to progression. DCE-US before treatment, and at 2 weeks and 8 weeks after the first Aflibercept administration.

Primary Outcome Measures

Name	Time	Method
Overall survival	1 year

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	1 year