Safety and Effectiveness Study of Chemotherapy and Ziv-aflibercept to Treat Metastatic Colorectal Cancer

Sponsor
NSABP Foundation Inc
Study ID
NCT01889680
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 5-FU — DRUG
    400 mg/m2 IV bolus day 1 followed by 2400 mg/m2 continuous IV infusion over 46 hours (days 1 and 2) every 14 days until disease progression
  • LV — DRUG
    400 mg/m2 IV day 1 every 14 days until disease progression
  • ziv-aflibercept — DRUG
    4 mg/kg IV day 1 every 14 days for 6 cycles (induction regimen); 4 mg/kg IV day 1 every 14 days until disease progression (continuation regimen)
  • mFOLFOX6 — DRUG
    5-FU 400 mg/m2 IV bolus plus leucovorin 400 mg/m2 IV plus oxaliplatin 85 mg/m2 IV on day 1 followed by 5-FU 2400 mg/m2 continuous IV infusion over 46 hours (days 1 and 2) every 14 days

Study Details

FC-8 is a Phase II, multi-center randomized study of a continuation regimen of 5-FU/LV with ziv-aflibercept or 5-FU/LV alone (control arm) following the induction regimen of mFOLFOX6 and ziv-aflibercept as first-line therapy for patients with metastatic colorectal cancer. The primary aim of the study is to determine the value of adding ziv-aflibercept to the continuation regimen of 5-FU/LV in improving progression-free survival (PFS) of patients with metastatic colorectal cancer who have achieved at least stable disease after induction therapy. The secondary aim is to determine the overall objective response rate (complete, partial or stable responses) by Response Evaluation Criteria in Solid Tumors (RECIST 1.1).

Key Dates

Start date
Nov 30, 2014
Status verified
Nov 2014
Primary completion
May 31, 2016
Completion
May 31, 2018

Study Design

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

Arms

  • Active Comparator: Arm 1: 5-FU + LV
    Patients receive mFOLFOX6 plus ziv-aflibercept every 14 days for 6 cycles (induction regimen), followed by 5-FU/LV every 14 days until disease progression (continuation regimen)
  • Experimental: Arm 2: 5-FU + LV + ziv-aflibercept
    Patients receive mFOLFOX6 plus ziv-aflibercept every 14 days for 6 cycles (induction regimen), followed by 5-FU/LV plus ziv-aflibercept every 14 days until disease progression (continuation regimen)

Primary Outcome Measure

The time to disease progression [ Time Frame: From start of study through 5 months ]

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