MedTrace Logo

Study of FOLFIRI Plus Bevacizumab in Colorectal Cancer Patients

NCT00354978 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2011-10-21

Study results available
· View outcomes & findings →

Summary

Objectives:

1. To estimate progression-free survival (PFS) at 12 months in subjects with metastatic colorectal cancer who receive FOLFIRI \[folinic acid (leucovorin or LV), 5-Fluorouracil (5-FU), irinotecan) plus bevacizumab as first line treatment.
2. To determine the objective response rate and the duration of objective response in this population.
3. To assess overall survival (OS) in this population.
4. To measure the effect of treatment on intratumoral blood volume and microvascular permeability by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) in consenting patients in whom it is technically feasible.
5. To correlate plasma proteomics with response.
6. To assess the safety of this regimen.

Conditions

Interventions

DRUG

5-Fluorouracil

400 mg/m\^2 injection by vein Day 1 of 14 day cycle immediately after completion of leucovorin infusion. 2.4 g/m\^2 by vein over 46 hours over Days 1-3 of 14 day cycle immediately after completion of 400 mg/m\^2 injection.

DRUG

Bevacizumab

5 mg/kg over 90 minutes on Day 1 of first 14 day cycle as initial dose, administered alone without other drugs. 5 mg/kg by vein on Day 1 of 14 day cycle.

DRUG

Leucovorin

400 mg/m\^2 over 2-4 minutes by vein on Day 1 of 14 day cycle.

DRUG

Irinotecan

180 mg/m\^2 by vein over 90 minutes on Day 1 of 14 day cycle.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Pfizer

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Scott Kopetz, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT00354978 on ClinicalTrials.gov