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NCT00499369 · ClinicalTrials.gov registry record · Phase 3

Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer That Progressed During First-Line Therapy

A Phase 3 study, sponsored by National Cancer Institute (NCI).

Terminated
Registry status
Phase 3
Development phase
72
Enrollment target

NCT00499369: Clinical Trial Phase 3 study, sponsored by National Cancer Institute (NCI).

NCT00499369 is a Phase 3 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 72 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00499369, a Phase 3 study, was terminated before completion, sponsored by National Cancer Institute (NCI).

TERMINATED
Registry status
Phase 3
Development phase
72 participants
Enrollment target

Study Summary

This randomized phase III trial is studying giving irinotecan and cetuximab together with bevacizumab to see how well it works compared with giving irinotecan and cetuximab alone in treating patients with metastatic colorectal cancer that progressed during first-line therapy. Drugs used in chemotherapy, such as irinotecan, 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 cetuximab and 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 tumor cells by blocking blood flow to the tumor. It is not yet known whether irinotecan and cetuximab are more effective with or without bevacizumab in treating metastatic colorectal cancer.

Interventions

  • DRUG fluorouracil
  • BIOLOGICAL cetuximab
  • DRUG leucovorin calcium
  • BIOLOGICAL bevacizumab
  • DRUG irinotecan hydrochloride

Trial Details

FieldValue
Enrollment Target 72 participants
Start Date 2007-06
Est. Completion 2012-11
Phase Phase 3

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT00499369

The ClinicalTrials.gov registry entry for NCT00499369 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which fluorouracil is the first listed.

NCT00499369 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00499369 about?

NCT00499369 is a clinical study titled "Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With Metastatic Colorectal Cancer That Progressed During First-Line Therapy". This randomized phase III trial is studying giving irinotecan and cetuximab together with bevacizumab to see how well it works compared with giving irinotecan and cetuximab alone in treating patients with metastatic colorectal cancer that progressed during first-line therapy. Drugs used in chemother...

What is the current status of trial NCT00499369?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 72 participants. The study started on 2007-06. Estimated completion is 2012-11.

What interventions are being tested in trial NCT00499369?

The interventions under investigation include: fluorouracil (DRUG), cetuximab (BIOLOGICAL), leucovorin calcium (DRUG), bevacizumab (BIOLOGICAL), irinotecan hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00499369?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 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.