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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
UMR-S Inserm 1036
Information provided by (Responsible Party):
Centre Leon Berard
ClinicalTrials.gov Identifier:
NCT01405430
First received: July 26, 2011
Last updated: January 30, 2014
Last verified: January 2014
  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: 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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Evaluation of ACE and Ca19-9

  • Evaluation of vascular toxicities [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Assess the link between vascular toxicities and VE-cadherin rate. These toxicities will be assessed during the follow-up of patients.


Estimated Enrollment: 100
Study Start Date: May 2010
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01405430

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

Publications:

Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT01405430     History of Changes
Other Study ID Numbers: AVECC, ET2010-003
Study First Received: July 26, 2011
Last Updated: January 30, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on August 19, 2014