Bevacizumab + Triplet Treatment for Untreated With Chemotherapy Metastatic Colorectal Cancer

Sponsor
Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
Study ID
NCT02497157
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to evaluate the efficacy and safety of fluorouracil (5-FU), levofolinate calcium (l-LV), oxaliplatin (L-OHP) and irinotecan hydrochloride hydrate (CPT-11) (FOLFOXIRI) plus bevacizumab in untreated metastatic colorectal cancer patients who harbor Uridine diphosphate (UDP)-glucuronosyl transferase 1A1 (UGT1A1) \*1/\*1, \*1/\*6 or \*1/\*28.

Key Dates

Start date
May 21, 2015
Status verified
Jun 2020
Primary completion
Jun 30, 2019
Completion
Jun 30, 2019

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Patients receive FOLFOXIRI plus bevacizumab \[oxaliplatin (L-OHP): 85 mg/sq.m., irinotecan hydrochloride hydrate (CPT-11): 165 mg/sq.m., continuous intravenous infusion of fluorouracil (CIV 5-FU): 3,200 mg/sq.m., Levofolinate calcium (l-LV): 200 mg/sq.m., bevacizumab: 5 mg/kg\]. The treatment will be repeated every 2 weeks, for up to 12 cycles, unless the disease progression, unacceptable toxicity, tumor resection or consent withdrawal.

Primary Outcome Measure

Response rate (RR) by response evaluation criteria in solid tumors (RECIST v1.1) [ Time Frame: Up to 18 months ]

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