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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 12, 2011
Last Updated Date	September 20, 2011
Start Date ^ICMJE	June 2009
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: September 20, 2011)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01437618 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	First-line FOLFOXIRI Plus Bevacizumab in BRAF Mutant Metastatic Colorectal Cancer
Official Title ^ICMJE	FOLFOXIRI Plus Bevacizumab as First-line Treatment for BRAF V600E Mutant Metastatic Colorectal Cancer: a Prospective Evaluation
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 Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	BRAF mutant mCRC
Condition ^ICMJE	Metastatic Colorectal Cancer
Intervention ^ICMJE	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
Study Group/Cohort (s)	BRAF mutant mCRC Intervention: Drug: FOLFOXIRI plus bevacizumab
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	15
Completion Date	May 2011
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 75 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Italy

Administrative Information
NCT Number ^ICMJE	NCT01437618
Other Study ID Numbers ^ICMJE	BRAF-0809-TRIBV
Has Data Monitoring Committee	Not Provided
Responsible Party	Alfredo Falcone, Azienda Ospedaliero, Universitaria Pisana
Study Sponsor ^ICMJE	Azienda Ospedaliero, Universitaria Pisana
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Azienda Ospedaliero, Universitaria Pisana
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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