Exploratory Study in Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver Metastases

Sponsor
EPS Corporation
Study ID
NCT01834014
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
  • Cetuximab — DRUG
    250 mg/m2 intravenously administered over 60 minutes (400 mg/m2 over 120 minutes as the initial dose) on day 1 and day 8 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
  • L-OHP — DRUG
    85 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
  • l-LV — DRUG
    200 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
  • 5-FU — DRUG
    400 mg/m2 intravenous bolus on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
  • 5-FU — DRUG
    2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.

Study Details

The correlation between the values of angiogenesis-related growth factors in plasma and efficacy, and biomarkers relevant as prognostic factors or predictive factors for sensitivity or resistance to treatment will be examined exploratively.

Key Dates

First listed
Apr 17, 2013
Start date
May 31, 2013
Status verified
Aug 2017
Primary completion
Mar 31, 2017
Completion
Mar 31, 2017

Study Design

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

Arms

  • Experimental: mFOLFOX + Bmab
    mFOLFOX plus bevacizumab
  • Active Comparator: mFOLFOX + Cmab
    mFOLFOX plus cetuximab

Primary Outcome Measure

To evaluate the values of angiogenesis-related growth factors in plasma with Progression-free survival (PFS) [ Time Frame: Baseline, Cycle 8, Progression Disease ]

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