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NCT00590681 · ClinicalTrials.gov registry record · Phase 2

Bevacizumab and Temozolomide Following Radiation and Chemotherapy for Newly Diagnosed Glioblastoma Multiforme

A Phase 2 study, sponsored by University of Chicago.

Completed
Registry status
Phase 2
Development phase
62
Enrollment target

NCT00590681: Completed Phase 2 study, sponsored by University of Chicago.

NCT00590681 is a Phase 2 study that has completed, run by University of Chicago. The registered enrollment target is 62 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00590681, a Phase 2 study, has completed, sponsored by University of Chicago.

COMPLETED
Registry status
Phase 2
Development phase
62 participants
Enrollment target

Study Summary

This study is being conducted to help determine whether the addition of Avastin (an anti-cancer drug), when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with GBM live. This study is sponsored by Genentech, Inc., the manufacturer of Avastin. Avastin is the experimental drug being administered in this research study. Avastin binds a protein called vascular endothelial growth factor, or VEGF. VEGF is produced by tumors and circulates in the blood. One of VEGF's main roles is to support the growth of new blood vessels. During cancer, VEGF promotes the growth of blood vessels that bring nutrients to tumor cells and help them grow. Avastin binds to VEGF, which then prevents VEGF from functioning. In laboratory studies, Avastin prevented the growth of several different types of cancer cells grown in animals. Avastin was approved by the Food and Drug Administration (FDA) for the treatment of metastatic colorectal cancer in combination with chemotherapy. Avastin has not been approved by the FDA for the treatment of GBM and is, therefore, considered experimental. Avastin is currently undergoing testing (alone and in combination with another anti-cancer drug, irinotecan) in persons with GBM that have come back after conventional treatment. Temozolomide (Temodar) is an anti-cancer drug that works by interfering with the growth of cells (including cancer cells) by stopping their division. Temozolomide was approved by the U.S. FDA for the treatment of newly diagnosed GBM in 2005. Avastin and temozolomide are currently being used together in several research studies involving people with newly diagnosed GBM. Limited information is available about either the safety or effectiveness of this drug combination.

Primary Outcome

The best clinical response rates determined and 95% confidence intervals obtained using the exact binomial distribution.

Interventions

  • DRUG Bevacizumab and Temozolomide

Trial Details

FieldValue
Enrollment Target 62 participants
Start Date 2007-02
Est. Completion 2014-09
Phase Phase 2
University of Chicago

796 total trials

What the finished NCT00590681 record still lists

NCT00590681 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (53% lower).

The record links to 0 conditions, and to 1 intervention - of which Bevacizumab and Temozolomide is the first listed.

NCT00590681 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00590681 about?

NCT00590681 is a clinical study titled "Bevacizumab and Temozolomide Following Radiation and Chemotherapy for Newly Diagnosed Glioblastoma Multiforme". This study is being conducted to help determine whether the addition of Avastin (an anti-cancer drug), when given along with temozolomide during the monthly cycles that follow radiation, is able to delay tumor growth, shrink tumors, or impact how long people with GBM live. This study is sponsored by...

What is the current status of trial NCT00590681?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 62 participants. The study started on 2007-02. Estimated completion is 2014-09.

What interventions are being tested in trial NCT00590681?

The interventions under investigation include: Bevacizumab and Temozolomide (DRUG).

Who is sponsoring clinical trial NCT00590681?

This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00590681's enrollment target sits among peer trials

62 1016th of 2000 higher than 975 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 NCT00590681, the US trial registry maintained by the National Library of Medicine. NCT00590681 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.