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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Azienda Ospedaliero, Universitaria Pisana.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Azienda Ospedaliero, Universitaria Pisana
ClinicalTrials.gov Identifier:
NCT01363739
First received: May 31, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  Purpose

-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
Metastatic Colorectal Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliero, Universitaria Pisana:

Primary Outcome Measures:
  • Progression-Free Survival [ Designated as safety issue: No ]
    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:
  • Response Rate [ Designated as safety issue: No ]
    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)

  • Overal survival [ Designated as safety issue: No ]
    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


Estimated Enrollment: 265
Study Start Date: April 2009
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Metastatic colorectal cancer patients receiving FOLFIRI plu Bevacizumab as first-line treatment

Criteria

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:

  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: NCT01363739

Locations
Italy
Polo Oncologico Azienda Ospedaliero, Universitaria Pisana Recruiting
Pisa, Italy, 56126
Contact: Fotios Loupakis, MD    050992466 ext +39    fotiosloupakis@gmail.com   
Principal Investigator: Alfredo Falcone, MD         
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Pisana
  More Information

No publications provided

Responsible Party: Alfredo Falcone, Azienda Ospedaliero, Universitaria Pisana
ClinicalTrials.gov Identifier: NCT01363739     History of Changes
Other Study ID Numbers: 3108
Study First Received: May 31, 2011
Last Updated: May 31, 2011
Health Authority: Italy: Ethics Committee

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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
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 July 28, 2014