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NCT00069888 · ClinicalTrials.gov registry record · Phase 2
A Phase II Trial of Adjuvant Docetaxel in Patients At High Risk of Relapse Following Prostatectomy
A Phase 2 study, sponsored by Sanofi.
- Completed
- Registry status
- Phase 2
- Development phase
- 83
- Enrollment target
NCT00069888 is a Phase 2 study that has completed, run by Sanofi. The registered enrollment target is 83 participants.
The verdict
NCT00069888, a Phase 2 study, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 83 participants
- Enrollment target
Study Summary
This clinical trial is designed to study whether docetaxel (Taxotere) helps reduce the risk of relapse in patients with prostate cancer who have had their prostate removed by surgery, but are at high risk of their cancer recurring. During the trial, doctors will also closely monitor patients for side effects of the chemotherapy. Docetaxel is a chemotherapy drug that prevents tumor cells from dividing, so they stop growing or die. Doctors use docetaxel to treat lung and breast cancer, and studies show it can help shrink tumors in some patients with prostate cancer that has spread to other parts of their bodies. The researchers conducting this study want to determine if docetaxel also helps reduce the likelihood of prostate cancer returning after surgery has removed the original tumor. All of the study participants will receive up to 18 doses of docetaxel, each administered through a needle inserted into a vein. Each round of treatment will consist of 30-minute, weekly infusions for three consecutive weeks, followed by one week with no chemotherapy. Before and after the chemotherapy, patients will take dexamethasone, an oral steroid that reduces the risk of an allergic reaction to the medication. If the side effects of the treatment become too intense, doctors may modify, delay, or even stop chemotherapy during the trial.
Interventions
- DRUG Docetaxel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2001-11 |
| Est. Completion | 2007-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00069888
The ClinicalTrials.gov registry entry for NCT00069888 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Docetaxel is the first listed.
NCT00069888 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00069888 about?
NCT00069888 is a clinical study titled "A Phase II Trial of Adjuvant Docetaxel in Patients At High Risk of Relapse Following Prostatectomy". This clinical trial is designed to study whether docetaxel (Taxotere) helps reduce the risk of relapse in patients with prostate cancer who have had their prostate removed by surgery, but are at high risk of their cancer recurring. During the trial, doctors will also closely monitor patients for sid...
What is the current status of trial NCT00069888?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2001-11. Estimated completion is 2007-01.
What interventions are being tested in trial NCT00069888?
The interventions under investigation include: Docetaxel (DRUG).
Who is sponsoring clinical trial NCT00069888?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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