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Completed

NCT Number: NCT01405430

Exploration of 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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Metastasis Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Léon Bérard, Lyon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bevacizumab + blood samples

Biological

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Collaborators

  • UMR-S Inserm 1036

Registry information

Official study title

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

Acronym: AVECC

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jul 29, 2011
Registry last updated
Jun 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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