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NCT00672009 · ClinicalTrials.gov registry record · Phase 2
A Study of Ixabepilone Before Surgery for High-Risk Localized Prostate Cancer
A Phase 2 study, sponsored by Cedars-Sinai Medical Center.
- Terminated
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
NCT00672009 is a Phase 2 study that was terminated before completion, run by Cedars-Sinai Medical Center. The registered enrollment target is 11 participants.
The verdict
NCT00672009, a Phase 2 study, was terminated before completion, sponsored by Cedars-Sinai Medical Center.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 11 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine the safety and effectiveness of the investigational drug, Ixabepilone, in men with high risk prostate cancer who plan to receive surgery. Prostate cancer is a common and important health issue facing men in the United States. Most patients with prostate cancer are identified when the disease is limited to the prostate gland itself (localized prostate cancer). A standard treatment for some patients with localized prostate cancer is removal of the prostate gland in an operation known as a "radical prostatectomy." A sub-set of patients with localized prostate cancer can be identified who are at high-risk of suffering a recurrence of prostate cancer after radical prostatectomy. For these patients, additional treatments are being investigated to combine with surgery in the hopes of increasing the chances for cure. Several kinds of chemotherapy medicines have been used for advanced prostate cancer which returns after initial therapy. Epothilones are a newly developed class of chemotherapy drugs that appear promising for the treatment of many forms of cancer. Ixabepilone is drug in the epothilone class of chemotherapy medicines that has shown encouraging results for the treatment of advanced prostate cancer and other cancers in clinical trials. This trial will include men with high-risk localized prostate cancer who will receive treatment with ixabepilone (4 cycles over 12 weeks) prior to radical prostatectomy. The goal of this trial will be to determine if analysis of genes and proteins in prostate cancer tissue taken before and after treatment can be used to predict ixabepilone response. In addition, this trial will evaluate the safety and feasibility of administering ixabepilone prior to radical prostatectomy for patients at high-risk of developing recurrent prostate cancer. The study has three phases: Screening, Treatment and Follow-up * Screening: Eligibility will be verified * Treatment: Subjects will receive Ix
Interventions
- DRUG Ixabepilone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2008-04 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00672009
The ClinicalTrials.gov registry entry for NCT00672009 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ixabepilone is the first listed.
NCT00672009 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00672009 about?
NCT00672009 is a clinical study titled "A Study of Ixabepilone Before Surgery for High-Risk Localized Prostate Cancer". The purpose of this research study is to determine the safety and effectiveness of the investigational drug, Ixabepilone, in men with high risk prostate cancer who plan to receive surgery. Prostate cancer is a common and important health issue facing men in the United States. Most patients with pro...
What is the current status of trial NCT00672009?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2008-04. Estimated completion is 2012-08.
What interventions are being tested in trial NCT00672009?
The interventions under investigation include: Ixabepilone (DRUG).
Who is sponsoring clinical trial NCT00672009?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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