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

Completed

• Conditions: Metastatic Colorectal Cancer
• Interventions: Drug: FOLFOXIRI plus bevacizumab

• Registration Number: NCT01437618
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study Completion: 2011-05
• Study First Submitted: 2011-07-12
• Status Verified: 2011-09
• Study First Submitted QC: 2011-09-20
• Last Update Submitted: 2011-09-20
• Study First Posted: 2011-09-21
• Last Update Posted: 2011-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BRAF mutant mCRC	FOLFOXIRI plus bevacizumab	-

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	About 24-30 months (From treatment initiation to evidence of progression or death from any cause)

Trial Locations

Locations (1)

Azienda Ospedaliero-Universitaria Pisana; 🇮🇹 Pisa, Italy