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NCT00354978 · ClinicalTrials.gov registry record · Phase 2

Study of FOLFIRI Plus Bevacizumab in Colorectal Cancer Patients

A Phase 2 study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 2
Development phase
49
Enrollment target

NCT00354978: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.

NCT00354978 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 49 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00354978, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
49 participants
Enrollment target

Study 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.

Interventions

  • DRUG Bevacizumab
  • DRUG Leucovorin
  • DRUG Irinotecan
  • DRUG 5-Fluorouracil

Trial Details

FieldValue
Enrollment Target 49 participants
Start Date 2005-01
Est. Completion 2011-03
Phase Phase 2

Sponsor

M.D. Anderson Cancer Center

2,692 total trials

What the Registry Record Tells You About NCT00354978

The ClinicalTrials.gov registry entry for NCT00354978 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Bevacizumab is the first listed.

NCT00354978 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00354978 about?

NCT00354978 is a clinical study titled "Study of FOLFIRI Plus Bevacizumab in Colorectal Cancer Patients". 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 t...

What is the current status of trial NCT00354978?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 49 participants. The study started on 2005-01. Estimated completion is 2011-03.

What interventions are being tested in trial NCT00354978?

The interventions under investigation include: Bevacizumab (DRUG), Leucovorin (DRUG), Irinotecan (DRUG), 5-Fluorouracil (DRUG).

Who is sponsoring clinical trial NCT00354978?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.