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Treating Patients With Metastatic Prostate Cancer Not Responding to Hormone and Chemotherapy
NCT00331344 · View on ClinicalTrials.gov ↗
Study Summary
This phase I/II trial is studying the side effects and best dose of ixabepilone and mitoxantrone hydrochloride when given together with prednisone and to see how well they work in treating patients with metastatic prostate cancer that did not respond to hormone therapy and chemotherapy. Drugs used in chemotherapy, such as ixabepilone, mitoxantrone hydrochloride, and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells
Conditions Studied
Interventions
- DRUG prednisone
- DRUG ixabepilone
- DRUG mitoxantrone hydrochloride
Study Locations (2)
California
- UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco
Wisconsin
- University of Wisconsin Hospital and Clinics — Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2006-04 |
| Est. Completion | 2010-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00331344
The ClinicalTrials.gov registry entry for NCT00331344 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Recurrent Prostate Cancer appearing as the primary indexed condition, and to 3 interventions — of which prednisone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00331344 reports 2 study locations spanning 2 distinct geographic areas — top geographies include California, Wisconsin. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00331344 about?
NCT00331344 is a clinical study titled "Treating Patients With Metastatic Prostate Cancer Not Responding to Hormone and Chemotherapy". This phase I/II trial is studying the side effects and best dose of ixabepilone and mitoxantrone hydrochloride when given together with prednisone and to see how well they work in treating patients with metastatic prostate cancer that did not respond to hormone therapy and chemotherapy. Drugs used i...
What is the current status of trial NCT00331344?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2006-04. Estimated completion is 2010-11.
What conditions does trial NCT00331344 study?
This clinical trial studies the following conditions: Recurrent Prostate Cancer, Stage IV Prostate Cancer, Adenocarcinoma of the Prostate. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00331344?
The interventions under investigation include: prednisone (DRUG), ixabepilone (DRUG), mitoxantrone hydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00331344?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00331344 being conducted?
This trial has 2 study locations across California, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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