Clinical trial NCT01405430: Exploration of Circulating VE-cadherin in Metastatic Colorectal Adenocarcinoma Patients Treated With Bevacizumab
Official title: Exploration of New Biologic Factors' Predictive Value , Especially Circulating VE-cadherin in Metastatic Colorectal Adenocarcinoma Patients Treated With Bevacizumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Metastasis
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: UMR-S Inserm 1036
First posted: 2011-07-29
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Response rate to treatment
timeFrame: Up to 1 year at most
Secondary outcomes:
measure: Clinical benefit
timeFrame: At progression or up to 1 year at most
measure: Evaluation of progression-free survival
timeFrame: From the beginning of treatment to progression, death or last available information
measure: Evaluation of overall survival
timeFrame: From the beginning of treatment to death or last available information
measure: Evaluation of tumoral markers
timeFrame: At progression with bevacizumab or up to 1 year of follow-up at most
measure: Evaluation of vascular toxicities
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: LYON Cedex 08
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz
Study officials:
affiliation: Centre Leon Berard
name: Christelle DE LA FOUCHARDIERE, MD
role: PRINCIPAL_INVESTIGATOR
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