FOLFOXIRI Plus Bevacizumab as First-line Treatment for BRAF V600E Mutant Metastatic Colorectal Cancer: a Prospective Evaluation

Azienda Ospedaliero, Universitaria Pisana1 site in 1 country15 target enrollmentJune 2009

ConditionsMetastatic Colorectal Cancer

InterventionsFOLFOXIRI plus bevacizumab

DrugsFOLFOXIRI plus bevacizumab

Overview

Phase: Not Applicable
Intervention: FOLFOXIRI plus bevacizumab
Conditions: Metastatic Colorectal Cancer
Sponsor: Azienda Ospedaliero, Universitaria Pisana
Enrollment: 15
Locations: 1
Primary Endpoint: Progression-Free Survival
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to prospectively verify if FOLFOXIRI plus bevacizumab as first-line treatment could be considered a promising approach to improve the outcome of BRAF mutant metastatic colorectal cancer patients

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

May 2011

Last Updated

14 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Azienda Ospedaliero, Universitaria Pisana

Responsible Party

Principal Investigator

Alfredo Falcone

Professor Alfredo Falcone

Azienda Ospedaliero, Universitaria Pisana

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed colorectal adenocarcinoma;
•Availability of formalin-fixed paraffin embedded tumor block from primary and/or metastasis;
•BRAF V600E mutant status of primary colorectal cancer and/or related metastasis;
•Unresectable and measurable metastatic disease according to RECIST criteria;
•Male or female, aged \> 18 years and \< 75 years;
•ECOG PS \< 2 if aged \< 71 years;
•ECOG PS = 0 if aged 71-75 years;
•Life expectancy of more than 3 months;
•Adequate haematological function: ANC ≥ 1.5 x 10\^9/L; platelets ≥ 100 x 10\^9/L, Hb ≥ 9 g/dL;
•Adequate liver function: serum bilirubin ≤ 1.5 x ULN; alkaline phosphatase and transaminases ≤ 2.5 x ULN (in case of liver metastases ≤ 5 x ULN);

Exclusion Criteria

•Presence or history of CNS metastasis;
•Serious, non-healing wound, ulcer, or bone fracture;
•Evidence of bleeding diathesis or coagulopathy;
•Uncontrolled hypertension;
•Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (CVA) (≤6 months before treatment start), myocardial infarction (≤ 6 months before treatment start), unstable angina, NYHA ≥ grade 2 chronic heart failure (CHF), uncontrolled arrhythmia;
•Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes;
•Chronic, daily treatment with high-dose aspirin (\>325 mg/day);
•Symptomatic peripheral neuropathy ≥ 2 grade NCIC-CTG criteria;
•Active uncontrolled infections;
•Treatment with any investigational drug within 30 days prior to enrolment;