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

Metastatic Colorectal Cancer Clinical Trial

— PROVETTA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01363739
• Other study ID #: 3108
• Status: Recruiting
• Phase: N/A
• First received: May 31, 2011
• Last updated: May 31, 2011
• Start date: April 2009

Study information

• Verified date: May 2011
• Source: Azienda Ospedaliero, Universitaria Pisana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 265
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Metastatic Colorectal Cancer

Locations

Country	Name	City	State
Italy	Polo Oncologico Azienda Ospedaliero, Universitaria Pisana	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero, Universitaria Pisana

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		No
Secondary	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)		No
Secondary	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		No