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NCT00449163 · ClinicalTrials.gov registry record · Phase 2

Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer

A Phase 2 study, sponsored by University of Miami.

Terminated
Registry status
Phase 2
Development phase
25
Enrollment target

NCT00449163: Clinical Trial Phase 2 study, sponsored by University of Miami.

NCT00449163 is a Phase 2 study that was terminated before completion, run by University of Miami. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00449163, a Phase 2 study, was terminated before completion, sponsored by University of Miami.

TERMINATED
Registry status
Phase 2
Development phase
25 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan, floxuridine, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of colorectal cancer by blocking blood flow to the tumor. Giving combination chemotherapy together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with bevacizumab works in treating patients with stage IV colorectal cancer.

Primary Outcome

Percentage of patients with overall survival times of up to 2 years

Interventions

  • DRUG Leucovorin
  • DRUG Irinotecan
  • BIOLOGICAL Bevacizumab
  • DRUG Floxuridine

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2006-03-01
Est. Completion 2010-03
Phase Phase 2
University of Miami

721 total trials

Why NCT00449163 stopped before completion

NCT00449163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).

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

NCT00449163 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00449163 about?

NCT00449163 is a clinical study titled "Combination Chemotherapy and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer". RATIONALE: Drugs used in chemotherapy, such as irinotecan, floxuridine, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some ...

What is the current status of trial NCT00449163?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2006-03-01. Estimated completion is 2010-03.

What interventions are being tested in trial NCT00449163?

The interventions under investigation include: Leucovorin (DRUG), Irinotecan (DRUG), Bevacizumab (BIOLOGICAL), Floxuridine (DRUG).

Who is sponsoring clinical trial NCT00449163?

This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00449163's enrollment target sits among peer trials

25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00449163, the US trial registry maintained by the National Library of Medicine. NCT00449163 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.