First-line FOLFOXIRI Plus Bevacizumab in BRAF Mutant Metastatic Colorectal Cancer

September 20, 2011 updated by: Alfredo Falcone, Azienda Ospedaliero, Universitaria Pisana

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pisa, Italy, 56126
        • Azienda Ospedaliero-Universitaria Pisana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

BRAF mutant mCRC

Description

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);
  • Serum creatinine ≤ 1.5 x ULN;
  • Previous adjuvant chemotherapy is allowed if more than 12 months have elapsed between the end of adjuvant therapy and first relapse;
  • At least 6 weeks from prior extended radiotherapy and 4 weeks from surgery;
  • Written informed consent to experimental treatment and molecular analyses.

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;
  • Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of curatively treated basal and squamous cell carcinoma of the skin or in situ cancer of the cervix;
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start;
  • Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome;
  • Fertile women (< 2 years after last menstruation) and men of childbearing potential not willing to use effective means of contraception.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BRAF mutant mCRC
Drug: FOLFOXIRI plus bevacizumab
  • BEVACIZUMAB 5 mg/Kg i.v. over 30', day 1 followed by
  • IRINOTECAN 165 mg/sqm i.v. over 1-h, day 1 followed by
  • OXALIPLATIN 85 mg/sqm i.v. over 2-h, day 1 concomitantly with
  • l-LV 200 mg/sqm i.v. over 2-h, day 1 followed by
  • 5-FLUOROURACIL 3200 mg/sqm i.v. 48-h continuous infusion, starting on day 1 Cycles repeated every 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival
Time Frame: About 24-30 months (From treatment initiation to evidence of progression or death from any cause)
About 24-30 months (From treatment initiation to evidence of progression or death from any cause)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero, Universitaria Pisana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

July 12, 2011

First Submitted That Met QC Criteria

September 20, 2011

First Posted (Estimate)

September 21, 2011

Study Record Updates

Last Update Posted (Estimate)

September 21, 2011

Last Update Submitted That Met QC Criteria

September 20, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRAF-0809-TRIBV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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