The purpose of this study to assess efficacy and tolerability of combination therapy FOLFOXIRI with Bevacizumab (BV) as a first-line therapy in patients with metastatic colorectal cancer.
This is a single-arm, multicentre phase II study evaluating the efficacy and safety of Bevacizumab (BV) in combination with oxaliplatin, irinotecan hydrochloride, fluorouracil, and leucovorin calcium regimen ( FOLFOXIRI +BV ; Falcone et al. ASCO2013) as first-line treatment for Japanese metastatic colorectal cancer patients. This study is composed two steps because of collecting safety issue in Japanese patient. As First step (Step 1), It assess on the initial safety information in ten Japanese patients of the end of 2nd cycle. it is evaluated by DMC. In parallel with the confirmation of the initial safety issue, register up to 65 cases in total and Step 1 patient, to evaluate the efficacy and safety (Step2).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
69
EPS Corporation
Shinjuku, Tokyo, Japan
Progression-free survival (PFS) at 10 months
PFS by investigator-reported measurements according to CT image. PFS was calculated from the day of treatment start to the first observation of progression disease (PD) or death from any cause. PD was defined as Overall Response by RECIST criteria v1.1 according to CT image.
Time frame: PFS rate at 10 months from study entry
Response rate (RR) by central review.
Response evaluation was performed according to RECIST criteria v1.1.
Time frame: Up to 18 months
Response rate (RR) by investigator-reported measurements.
Response evaluation was performed according to RECIST criteria v1.1.
Time frame: Up to 30 months
PFS by central review according to CT image.
PFS was calculated from the day of treatment start to the first observation of progression disease (PD) or death from any cause.
Time frame: Up to 18 months
Overall survival (OS)
OS was calculated from the day of registration in this study to death from any cause.
Time frame: Up to 30 months
Efficacy by RAS status ; RR,PFS,OS
RR,PFS,OS according to tumor RAS status.
Time frame: Up to 30 months
Incidence of adverse events
Adverse events were evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All adverse events was collected in duration from starting treatment to whichever shorter "after 30 days from withdrawal treatment" or "later treatment was started".
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Given IV
Given IV
Time frame: Up to 30 months
Time to treatment-failure
Time frame: Up to 30 months
Completion rate in Induction treatment
Time frame: Up to 30 months
Relative Dose Intensity
Time frame: Up to 30 months
Treatment duration
Time frame: Up to 30 months