Exploration of Circulating VE-cadherin in Metastatic Colorectal Adenocarcinoma Patients Treated With Bevacizumab (AVECC)

June 26, 2015 updated by: Centre Leon Berard

Exploration of New Biologic Factors' Predictive Value , Especially Circulating VE-cadherin in Metastatic Colorectal Adenocarcinoma Patients Treated With Bevacizumab

It is a prospective, non-randomized, monocentric study. The purpose of the study is to assess the predictive value of VE-cadherin on the objective tumor response.

Biological factors will be correlated to clinical outcome measures.

100 patients treated with bevacizumab for a metastatic colorectal adenocarcinoma will be enrolled.

Patients will be followed every 10 weeks until progression in spite of bevacizumab or until they stop bevacizumab because of toxicity.

Bevacizumab will be administered according to investigators appreciation.

Blood samples will be collected at enrollment, at second bevacizumab's administration and every 10 weeks until progression, or until patients stop bevacizumab because of toxicity or until one year at most in case that patients still receive bevacizumab.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

63

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • LYON Cedex 08, France, 69373
        • Centre Leon Berard
      • Lyon, France, 69008
        • Hôpital Privé Jean Mermoz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with a metastatic colorectal cancer proved histologically and treated with bevacizumab in first line.
  • At least one extra-osseous, non-irradiated, measurable site (>= 10 mm with spiral CT).
  • No prior radiotherapy treatment unless treatment is over for at least 4 weeks.
  • Adult patients.
  • PS <= 2.
  • Life expectancy greater than 3 months.
  • Mandatory affiliation with a healthy security insurance.
  • Signed written informed consent.

Exclusion Criteria:

  • Prior chemotherapy for the metastatic cancer.
  • Prior bevacizumab treatment.
  • Other current cancer or previous cancer detected in the last 5 years that can be linked to the current disease.
  • Patient deprived of freedom.
  • Pregnant or lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bevacizumab + blood samples
Biological: Bevacizumab + blood samples

Bevacizumab will be administered according to investigators appreciation.

Blood samples will be collected at enrollment, at second bevacizumab's administration and every 10 weeks until progression, or until patients stop bevacizumab because of toxicity or until one year at most in case that patients still receive bevacizumab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate to treatment
Time Frame: Up to 1 year at most

A 30% response rate (complete or partial response) to treatment is expected. The response will be assessed according to RECIST criteria. This primary outcome measure is defined by the observation of at least one objective response during the treatment.

This outcome measure will be correlated to biological factors.
Up to 1 year at most

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical benefit
Time Frame: At progression or up to 1 year at most

The clinical benefit is based on complete response, partial response or stable disease.

This outcome measure will be correlated to biological factors.
At progression or up to 1 year at most
Evaluation of progression-free survival
Time Frame: From the beginning of treatment to progression, death or last available information
This outcome measure will be correlated to biological factors.
From the beginning of treatment to progression, death or last available information
Evaluation of overall survival
Time Frame: From the beginning of treatment to death or last available information
This outcome measure will be correlated to biological factors.
From the beginning of treatment to death or last available information
Evaluation of tumoral markers
Time Frame: At progression with bevacizumab or up to 1 year of follow-up at most
Evaluation of ACE and Ca19-9
At progression with bevacizumab or up to 1 year of follow-up at most
Evaluation of vascular toxicities
Time Frame: Up to 1 year
Assess the link between vascular toxicities and VE-cadherin rate. These toxicities will be assessed during the follow-up of patients.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Leon Berard

Collaborators

UMR-S Inserm 1036

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

July 26, 2011

First Submitted That Met QC Criteria

July 27, 2011

First Posted (Estimate)

July 29, 2011

Study Record Updates

Last Update Posted (Estimate)

June 29, 2015

Last Update Submitted That Met QC Criteria

June 26, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AVECC
  • ET2010-003 (Other Identifier: Sponsor's identification)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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