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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01405430
First Posted: July 29, 2011
Last Update Posted: June 29, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
UMR-S Inserm 1036
Information provided by (Responsible Party):
Centre Leon Berard
  Purpose

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.


Condition Intervention
Colorectal Cancer Metastasis Biological: Bevacizumab + blood samples

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Exploration of New Biologic Factors' Predictive Value , Especially Circulating VE-cadherin in Metastatic Colorectal Adenocarcinoma Patients Treated With Bevacizumab

Resource links provided by NLM:


Further study details as provided by Centre Leon Berard:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


  • 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.

  • 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.

  • 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

  • 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.


Enrollment: 63
Study Start Date: May 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01405430


Locations
France
Centre Léon Bérard
LYON Cedex 08, France, 69373
Hôpital Privé Jean Mermoz
Lyon, France, 69008
Sponsors and Collaborators
Centre Leon Berard
UMR-S Inserm 1036
Investigators
Principal Investigator: Christelle DE LA FOUCHARDIERE, MD Centre Leon Berard
  More Information

Publications:

Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT01405430     History of Changes
Other Study ID Numbers: AVECC
ET2010-003 ( Other Identifier: Sponsor's identification )
First Submitted: July 26, 2011
First Posted: July 29, 2011
Last Update Posted: June 29, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Colorectal Neoplasms
Adenocarcinoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents