An Exploratory Study of Treatment Sensitivity and Prognostic Factors in a Efficacy and Safety Study of mFOLFOX6 + Bevacizumab Versus mFOLFOX6 + Panitumumab Therapy in Patients With Chemotherapy-naïve Unresectable Advanced or Recurrent Colorectal Cancer

Sponsor
Takeda
Study ID
NCT02394834
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 79 Years
Healthy Volunteers
Not accepted

Interventions

  • oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab — DRUG
    oxaliplatin (OXA), levofolinate calcium (l-LV), panitumumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion
  • oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab — DRUG
    oxaliplatin (OXA), levofolinate calcium (l-LV), bevacizumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion

Study Details

The purpose of this study is to investigate biomarkers which may be predictors of efficacy and safety of treatment with mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve unresectable advanced or recurrent colorectal cancer.

Key Dates

First listed
Mar 20, 2015
Start date
May 29, 2015
Status verified
Apr 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
757 participants (actual)

Arms

  • Arm: Group P; mFOLFOX6 + panitumumab combination therapy
    OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg mFOLFOX6 + panitumumab combination therapy, once every two weeks
  • Arm: Group B; mFOLFOX6 + bevacizumab combination therapy
    OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg/ mFOLFOX6 + bevacizumab combination therapy, once every two weeks

Primary Outcome Measure

Overall survival (OS) [ Time Frame: Up to approximately 63 months ]

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