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Completed Phase 2 Interventional Results available

Study of FOLFIRI Plus Bevacizumab in Colorectal Cancer Patients

ClinicalTrials.gov ID: NCT00354978

Public ClinicalTrials.gov record NCT00354978. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 8:39 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Phase II Study of Irinotecan, Leucovorin, 5-Fluorouracil (FOLFIRI) Plus Bevacizumab as First-Line Treatment for Metastatic Colorectal Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00354978
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Enrollment
49 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2004
Primary completion
Feb 28, 2011
Completion
Feb 28, 2011
Last update posted
Oct 20, 2011

2005 – 2011

United States locations

U.S. sites
2
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Lyndon Baines Johnson General Hospital Houston Texas 77030
UT MD Anderson Cancer Center Houston Texas 77030

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00354978, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 20, 2011 · Synced Sep 5, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00354978 live on ClinicalTrials.gov.

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