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

Not Applicable

Completed

• Conditions: Metastasis; Colorectal Cancer
• Interventions: Biological: Bevacizumab + blood samples

• Registration Number: NCT01405430
• Lead Sponsor: Centre Leon Berard

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2011-07-26
• Study First Submitted QC: 2011-07-27
• Study First Posted: 2011-07-29
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-26
• Last Update Posted: 2015-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bevacizumab + blood samples	Bevacizumab + blood samples	-

Primary Outcome Measures

Name	Time	Method
Response rate to treatment	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.

Secondary Outcome Measures

Name	Time	Method
Clinical benefit	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.
Evaluation of overall survival	From the beginning of treatment to death or last available information	This outcome measure will be correlated to biological factors.
Evaluation of tumoral markers	At progression with bevacizumab or up to 1 year of follow-up at most	Evaluation of ACE and Ca19-9
Evaluation of vascular toxicities	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.
Evaluation of progression-free survival	From the beginning of treatment to progression, death or last available information	This outcome measure will be correlated to biological factors.

Trial Locations

Locations (2)

Centre Léon Bérard; 🇫🇷 LYON Cedex 08, France

Hôpital Privé Jean Mermoz; 🇫🇷 Lyon, France