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Aflibercept and Chemotherapy as First Line Treatment for Metastatic Colorectal Cancer Assessable With DCE-US (PULSAR).

NCT02173990 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-10-20

No results posted yet for this study

Summary

The PULSAR trial is an international, investigator-initiated, single arm open-label phase II study. The aim of this study is to measure the clinical activity of the combination FOLFIRI-aflibercept in an homogeneous group of patients with metastatic colorectal cancer, and treated with a FOLFIRI-aflibercept regimen as first line treatment.

Conditions

Interventions

DRUG

Aflibercept-FOLFIRI

Aflibercept : 4 mg/kg, IV over 1 h on Day 1 FOLFIRI : * Irinotecan 180 mg/m² IV infusion in 500 mL D5W (5% Dextrose in Water solution) over 90 minutes and dl leucovorin\* 400 mg/m² IV infusion over 2 hours, at the same time, in bags using a Y-line, followed by : * 5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by : * 5-FU 2400 mg/m² continuous IV infusion in 500 mL over 46-hours. * \*400 mg/m² of leucovorin expressed in dl racemic. When the l-isomer form is used the dose should be divided by 2, i.e. 200 mg/m²

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Centre Oscar Lambret

    lead OTHER

Principal Investigators

  • Antoine ADENIS, MD, PhD · Centre Oscar Lambret - France

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2018-11-02
Completion
2019-10-22

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT02173990 on ClinicalTrials.gov