Optimization of Bevacizumab Scheduling With Chemotherapy for Metastatic Colorectal Cancer

Sponsor
National Cancer Institute, Naples
Study ID
NCT01718873
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.
  • Oxaliplatin — DRUG
    85mg/m2 IV every 2 weeks for up to 24 weeks
  • levo-folinic acid — DRUG
    200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks
  • 5-fluorouracil — DRUG
    400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)
  • Capecitabine — DRUG
    1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)

Study Details

The purpose of this study is to evaluate if giving bevacizumab prior to chemotherapy compared to giving bevacizumab at the same time as chemotherapy improves patient overall response to treatment.

Key Dates

First listed
Oct 31, 2012
Start date
May 31, 2012
Status verified
Oct 2021
Primary completion
Dec 31, 2015
Completion
Dec 31, 2019

Study Design

Enrollment
230 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: bevacizumab before chemotherapy
    Bevacizumab administered 4 days before each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)
  • Active Comparator: bevacizumab with chemotherapy
    Bevacizumab administered on the first day of each cycle of chemotherapy containing oxaliplatin (mFOLFOX-6 / mOXXEL)

Primary Outcome Measure

Objective Response Rate [ Time Frame: Objective response was assessed by computed tomographic scan or other appropriate imaging at weeks 12 and 24 from randomization, and every 3 months thereafter, assessed up to 90 months. ]

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