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

NCT02624726 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-02-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

5 Fluorouracil

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)

DRUG

Leucovorin

Leucovorin: 400mg/m2, i.v in 2 hours infusion (cycle repeated every two weeks)

DRUG

Irinotecan

Irinotecan: 180mg/m2, i.v in 90min infusion (cycle repeated every two weeks)

DRUG

Aflibercept

Aflibercept: 4mg/kg i.v in 1 hour infusion (cycle repeated every two weeks)

Sponsors & Collaborators

  • Hellenic Oncology Research Group

    lead OTHER

Principal Investigators

  • John Souglakos, MD · Hellenic Oncology Research Group

  • Athanasios Kotsakis, MD · Hellenic Oncology Research Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2018-10-31
Completion
2019-03-31

Countries

  • Greece

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02624726 on ClinicalTrials.gov