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

NCT01437618 | Completed

• 1 other identifier: BRAF-0809-TRIBV
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival

  About 24-30 months (From treatment initiation to evidence of progression or death from any cause)

Study Arms (1)

BRAF mutant mCRC

Drug: FOLFOXIRI plus bevacizumab

Interventions

FOLFOXIRI plus bevacizumab DRUG

* 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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

BRAF mutant mCRC

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Azienda Ospedaliero, Universitaria Pisana: lead

Study Sites (1)

Azienda Ospedaliero-Universitaria Pisana

Pisa, 56126, Italy

Location

Related Publications (1)

• Loupakis F, Cremolini C, Salvatore L, Masi G, Sensi E, Schirripa M, Michelucci A, Pfanner E, Brunetti I, Lupi C, Antoniotti C, Bergamo F, Lonardi S, Zagonel V, Simi P, Fontanini G, Falcone A. FOLFOXIRI plus bevacizumab as first-line treatment in BRAF mutant metastatic colorectal cancer. Eur J Cancer. 2014 Jan;50(1):57-63. doi: 10.1016/j.ejca.2013.08.024. Epub 2013 Oct 15.

  PMID: 24138831 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Alfredo Falcone

Study Record Dates

• First Submitted: July 12, 2011
• First Posted: September 21, 2011
• Study Start: June 1, 2009
• Study Completion: May 1, 2011
• Last Updated: September 21, 2011

Record last verified: 2011-09

Locations

IT (1)