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NCT00089609 · ClinicalTrials.gov registry record · Phase 2
Docetaxel, Thalidomide, Prednisone, and Bevacizumab to Treat Metastatic Prostate Cancer
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 73
- Enrollment target
NCT00089609: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00089609 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 73 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00089609, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 73 participants
- Enrollment target
Study Summary
This is a Phase II study of docetaxel, bevacizumab, prednisone and thalidomide in patients with androgen independent metastatic prostate cancer who are previously untreated with chemotherapy. The primary objective of this study is to determine if the combination of docetaxel, thalidomide and bevacizumab is able to be associated with a sufficiently high proportion of patients with a prostate-specific antigen (PSA) response to be worthy of further investigation in metastatic prostate cancer. We will also be looking at multiple secondary endpoints. These will include possible pharmacokinetic interactions among the study agents, potential correlation between patient genotype and efficacy of treatment. We will also be looking for circulating tumor cells in blood before and after treatment. Additionally we will be monitoring the tolerability of the regimen and survival duration as endpoints as well. We hope to use this trial to build on the promising results seen in our thalidomide/docetaxel protocol where there was a significant PSA decline and a trend toward survival benefit.
Primary Outcome
PSA response was assessed by the PSA Consensus Criteria. PSA decline is defined as a decline in PSA of at least 50% with no other evidence of disease progression.
Interventions
- DRUG Docetaxel
- DRUG Prednisone
- DRUG Thalidomide
- BIOLOGICAL bevacizumab
- GENETIC polymorphism analysis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2005-04-19 |
| Est. Completion | 2018-01-09 |
| Phase | Phase 2 |
What the finished NCT00089609 record still lists
NCT00089609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 5 interventions - of which Docetaxel is the first listed.
NCT00089609 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00089609 about?
NCT00089609 is a clinical study titled "Docetaxel, Thalidomide, Prednisone, and Bevacizumab to Treat Metastatic Prostate Cancer". This is a Phase II study of docetaxel, bevacizumab, prednisone and thalidomide in patients with androgen independent metastatic prostate cancer who are previously untreated with chemotherapy. The primary objective of this study is to determine if the combination of docetaxel, thalidomide and bevaciz...
What is the current status of trial NCT00089609?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 73 participants. The study started on 2005-04-19. Estimated completion is 2018-01-09.
What interventions are being tested in trial NCT00089609?
The interventions under investigation include: Docetaxel (DRUG), Prednisone (DRUG), Thalidomide (DRUG), bevacizumab (BIOLOGICAL), polymorphism analysis (GENETIC).
Who is sponsoring clinical trial NCT00089609?
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 NCT00089609's enrollment target sits among peer trials
73 924th of 2000 higher than 1,076 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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