Status:
COMPLETED
First-line FOLFOXIRI Plus Bevacizumab in BRAF Mutant Metastatic Colorectal Cancer
Lead Sponsor:
Azienda Ospedaliero, Universitaria Pisana
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-75 years
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 col...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT01437618
Start Date
June 1 2009
End Date
May 1 2011
Last Update
September 21 2011
Active Locations (1)
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1
Azienda Ospedaliero-Universitaria Pisana
Pisa, Italy, 56126