Trial in Metastatic Colorectal Cancer With FOLFIRI Plus Aflibercept as First Line Treatment

Sponsor
Hellenic Oncology Research Group
Study ID
NCT02624726
Phase
PHASE2
Status
Unknown

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • 5 Fluorouracil — DRUG
    5 Fluorouracil: 400mg/m2, bolus infusion in \<5min followed by 5 Fluorouracil: 2400mg/m2, i.v in 46 hours continuous infusion (cycle repeated every two weeks)
  • Leucovorin — DRUG
    Leucovorin: 400mg/m2, i.v in 2 hours infusion (cycle repeated every two weeks)
  • Irinotecan — DRUG
    Irinotecan: 180mg/m2, i.v in 90min infusion (cycle repeated every two weeks)
  • Aflibercept — DRUG
    Aflibercept: 4mg/kg i.v in 1 hour infusion (cycle repeated every two weeks)

Study Details

Investigators propose to study the combination of m FOLFIRI plus Aflibercept in a Phase II trial of patients with metastatic colorectal cancer. The promising results of aflibercept derived from preclinical studies and from clinical trials conducted in patients with refractory of recurrent to oxaliplatin-based 1st line treatment in patients with mCRC open the field to explore such therapeutic approaches in the 1st line setting in combination with the FOLFIRI regimen.

Key Dates

Start date
Jan 31, 2016
Status verified
Jan 2019
Primary completion
Oct 31, 2018
Completion
Mar 31, 2019

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: FOLFIRI/Aflibercept
    5 Fluorouracil/Leucovorin/Irinotecan/Aflibercept

Primary Outcome Measure

Overall Response Rate [ Time Frame: Disease evaluation at Week 8 ]

Related Studies