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

Study Overview
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Brief Summary
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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.

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

Conditions
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Colorectal Cancer, Metastasis

Intervention / Treatment
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* Biological: Bevacizumab + blood samples


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bevacizumab + blood samples<br> | Biological: Bevacizumab + blood samples<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate to treatment | 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 | 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 | 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 | This outcome measure will be correlated to biological factors. | From the beginning of treatment to death or last available information | 
| Evaluation of tumoral markers | Evaluation of ACE and Ca19-9 | At progression with bevacizumab or up to 1 year of follow-up at most | 
| Evaluation of vascular toxicities | 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 |