Evaluation of VEGF Polymorphism as Predictive Factor in Metastatic Colorectal Cancer Treated With Folfiri Plus Bevacizumab (PROVETTA)

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. Identifier: NCT01363739
Recruitment Status : Unknown
Verified May 2011 by Azienda Ospedaliero, Universitaria Pisana.
Recruitment status was:  Recruiting
First Posted : June 2, 2011
Last Update Posted : June 2, 2011
Information provided by:
Azienda Ospedaliero, Universitaria Pisana

Brief Summary:
-1498C/T VEGF polymorphism, as suggested by a recent retrospective analysis, seems to have a role in predicting the efficacy of Bevacizumab plus FOLFIRI in first-line treatment of metastatic colorectal cancer patients. The present study aims to prospectively evaluate the predictive role of this polymorphism in metastatic colorectal patients receiving the same treatment.

Condition or disease
Metastatic Colorectal Cancer

Study Type : Observational
Estimated Enrollment : 265 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of -1498 c/t VEGF Polymorphism in the Prediction of Benefit From First-line Folfiri Plus Bevacizumab in Metastatic Colorectal Cancer Patients
Study Start Date : April 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Primary Outcome Measures :
  1. Progression-Free Survival
    Progression free survival (PFS) is defined as time from study entry until progression of disease (according to RECIST 1.1) or death from any cause. Patients who are alive without having progressed at the end of the study will be censored at their last radiological assessment

Secondary Outcome Measures :
  1. Response Rate
    Response Rate (RR) is defined as the fraction of treated patients who achieve a response as defined according to Response Evaluation Criteria in Solid Tumors (RECIST)

  2. Overal survival
    Overall survival (OS) is defined as the time from study entry until death from any cause. Patients who are alive at the end of the study will be censored at that point

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Metastatic colorectal cancer patients receiving FOLFIRI plu Bevacizumab as first-line treatment

Inclusion Criteria:

  • Histologically confirmed colorectal adenocarcinoma;
  • Measurable metastatic disease according to RECIST criteria;
  • Patients receiving BV plus FOLFIRI as first-line treatment;
  • Written informed consent;
  • Availability of blood samples for genetic analysis.-

Exclusion Criteria:

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 identifier (NCT number): NCT01363739

Polo Oncologico Azienda Ospedaliero, Universitaria Pisana Recruiting
Pisa, Italy, 56126
Contact: Fotios Loupakis, MD    050992466 ext +39   
Principal Investigator: Alfredo Falcone, MD         
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Pisana

Responsible Party: Alfredo Falcone, Azienda Ospedaliero, Universitaria Pisana Identifier: NCT01363739     History of Changes
Other Study ID Numbers: 3108
First Posted: June 2, 2011    Key Record Dates
Last Update Posted: June 2, 2011
Last Verified: May 2011

Keywords provided by Azienda Ospedaliero, Universitaria Pisana:
VEGF polymorphism Bevacizumab

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents