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

July 12, 2011
September 20, 2011
June 2009
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT01437618 on ClinicalTrials.gov Archive Site
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First-line FOLFOXIRI Plus Bevacizumab in BRAF Mutant Metastatic Colorectal Cancer
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

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

BRAF mutant mCRC

Metastatic Colorectal Cancer
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
BRAF mutant mCRC
Intervention: Drug: FOLFOXIRI plus bevacizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
May 2011
Not Provided

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01437618
BRAF-0809-TRIBV
Not Provided
Alfredo Falcone, Azienda Ospedaliero, Universitaria Pisana
Azienda Ospedaliero, Universitaria Pisana
Not Provided
Not Provided
Azienda Ospedaliero, Universitaria Pisana
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP