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

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: NCT01437618
Recruitment Status : Completed
First Posted : September 21, 2011
Last Update Posted : September 21, 2011
Information provided by (Responsible Party):
Alfredo Falcone, Azienda Ospedaliero, Universitaria Pisana

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

Condition or disease Intervention/treatment
Metastatic Colorectal Cancer Drug: FOLFOXIRI plus bevacizumab

Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: FOLFOXIRI Plus Bevacizumab as First-line Treatment for BRAF V600E Mutant Metastatic Colorectal Cancer: a Prospective Evaluation
Study Start Date : June 2009
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Progression-Free Survival [ Time Frame: About 24-30 months (From treatment initiation to evidence of progression or death from any cause) ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
BRAF mutant mCRC

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.

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): NCT01437618

Azienda Ospedaliero-Universitaria Pisana
Pisa, Italy, 56126
Sponsors and Collaborators
Azienda Ospedaliero, Universitaria Pisana

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alfredo Falcone, Professor Alfredo Falcone, Azienda Ospedaliero, Universitaria Pisana Identifier: NCT01437618     History of Changes
Other Study ID Numbers: BRAF-0809-TRIBV
First Posted: September 21, 2011    Key Record Dates
Last Update Posted: September 21, 2011
Last Verified: September 2011

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