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

Sponsor
Centre Oscar Lambret
Study ID
NCT02173990
Phase
PHASE2
Status
Terminated

Conditions

  • Metastatic Colorectal Cancer

Eligibility Criteria

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

Interventions

  • Aflibercept-FOLFIRI — DRUG
    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

Study Details

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.

Key Dates

Start date
Jul 31, 2014
Status verified
Oct 2021
Primary completion
Nov 2, 2018
Completion
Oct 22, 2019

Study Design

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

Arms

  • Experimental: Aflibercept-FOLFIRI
    On day 1 of each cycle patients will receive aflibercept followed by irinotecan, 5-FU and leucovorin (FOLFIRI regimen). This treatment will be repeated every 2 weeks until RECIST progression or intolerance.

Primary Outcome Measure

Progression-Free Rate will be assessed according to RECIST 1.1 with central radiological review. [ Time Frame: At 10-month ]

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