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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alfredo Falcone, Azienda Ospedaliero, Universitaria Pisana
ClinicalTrials.gov Identifier:
NCT01437618
First received: July 12, 2011
Last updated: September 20, 2011
Last verified: September 2011
  Purpose

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 Intervention
Metastatic Colorectal Cancer
Drug: FOLFOXIRI plus bevacizumab

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Progression-Free Survival [ Time Frame: About 24-30 months (From treatment initiation to evidence of progression or death from any cause) ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: June 2009
Study Completion Date: May 2011
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

BRAF mutant mCRC

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);
  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01437618

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

No publications provided

Responsible Party: Alfredo Falcone, Professor Alfredo Falcone, Azienda Ospedaliero, Universitaria Pisana
ClinicalTrials.gov Identifier: NCT01437618     History of Changes
Other Study ID Numbers: BRAF-0809-TRIBV
Study First Received: July 12, 2011
Last Updated: September 20, 2011
Health Authority: Italy: The Italian Medicines Agency

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 August 01, 2014