Exploration of Circulating VE-cadherin in Metastatic Colorectal Adenocarcinoma Patients Treated With Bevacizumab (AVECC)
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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 |
- 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.
- 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 |
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| Contact: Ellen BLANC | +33 4 78 78 29 67 | ellen.blanc@lyon.unicancer.fr |
| Contact: Justine SEMAL | +33 4 78 78 29 22 | justine.semal@lyon.unicancer.fr |
| France | |
| Hôpital Privé Jean Mermoz | Recruiting |
| Lyon, France, 69008 | |
| Principal Investigator: Pascal ASTRU, MD | |
| Sub-Investigator: Gérard LLEDO, MD | |
| Sub-Investigator: Jérôme DESRAME, MD | |
| Centre Léon Bérard | Recruiting |
| LYON Cedex 08, France, 69373 | |
| Contact: Ellen BLANC +33 4 78 78 29 67 ellen.blanc@lyon.unicancer.fr | |
| Contact: Justine SEMAL +33 4 78 78 29 22 justine.semal@lyon.unicancer.fr | |
| Principal Investigator: Christelle DE LA FOUCHARDIERE, MD | |
| Sub-Investigator: Françoise DESSEIGNE, MD | |
| 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: | March 20, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Colorectal Neoplasms Neoplasm Metastasis Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous 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 May 22, 2013