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NCT00393094 · ClinicalTrials.gov registry record · Phase 2
Bevacizumab and Irinotecan to Treat Brain Tumors
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT00393094: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00393094 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00393094, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
Background: * Bevacizumab is a genetically engineered antibody that blocks the growth of new blood vessels in tumors. It has shown activity against human brain tumors in laboratory tests and human clinical trials. * Irinotecan causes damage to the deoxyribonucleic acid (DNA) in cancer cells so that the cells cannot reproduce or repair themselves. It is approved for treating patients with colorectal cancer. * Bevacizumab and irinotecan in combination are more effective against colon cancer than either drug alone. Objectives: * To determine the safety of bevacizumab and irinotecan and any side effects associated with the combination of the two drugs when given to patients with high grade gliomas. * To determine if the combination of bevacizumab and irinotecan can help patients with brain tumors that have grown after treatment with bevacizumab alone. Eligibility: -Patients 18 years of age and older who have been treated on National Cancer Institute (NCI) trial 06-C-0064 (NCT00271609), "Bevacizumab Alone for Recurrent Gliomas," and whose tumor has progressed. Design: Participants receive infusions of bevacizumab and irinotecan through a vein once every 2 weeks in 4-week treatment cycles, plus the following procedures: * History, physical and neurological examinations every 2 weeks for the first treatment cycle and then every 4 weeks * Magnetic Resonance Imaging (MRI) scan of the head every 4 weeks. * Routine lab every week. * Quality-of-life questionnaire every 4 weeks
Primary Outcome
Definition of response: complete response (CR) is the complete disappearance of all measurable and evaluable disease. Partial response (PR) is greater than or equal to a 50% decrease compared to baseline in the sum of products of perpendicular diameters of all measurable lesions. Stable/No response (SD, NR)does not qualify for CR, PR, or progression. Progression is a 25% increase in the sum of products of all measurable lesions (or two target lesions if too numerous over the smallest sum observe
Interventions
- BIOLOGICAL Bevacizumab
- DRUG Irinotecan hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2006-09 |
| Est. Completion | 2010-03 |
| Phase | Phase 2 |
Why NCT00393094 stopped before completion
NCT00393094 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Bevacizumab is the first listed.
NCT00393094 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00393094 about?
NCT00393094 is a clinical study titled "Bevacizumab and Irinotecan to Treat Brain Tumors". Background: * Bevacizumab is a genetically engineered antibody that blocks the growth of new blood vessels in tumors. It has shown activity against human brain tumors in laboratory tests and human clinical trials. * Irinotecan causes damage to the deoxyribonucleic acid (DNA) in cancer cells so that...
What is the current status of trial NCT00393094?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2006-09. Estimated completion is 2010-03.
What interventions are being tested in trial NCT00393094?
The interventions under investigation include: Bevacizumab (BIOLOGICAL), Irinotecan hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00393094?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00393094's enrollment target sits among peer trials
31 1578th of 2000 higher than 419 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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