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NCT00058084 · ClinicalTrials.gov registry record · Phase 2

Ixabepilone Compared With Mitoxantrone and Prednisone in Treating Patients With Refractory Metastatic Prostate Cancer

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
80
Enrollment target

NCT00058084: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT00058084 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00058084, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
80 participants
Enrollment target

Study Summary

This randomized phase II trial is studying ixabepilone to see how well it works compared to mitoxantrone and prednisone in treating patients with metastatic prostate cancer that has not responded to paclitaxel, docetaxel, or hormone therapy. Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Ixabepilone may reduce resistance to the drugs and allow the tumor cells to be killed. It is not yet known which chemotherapy regimen is more effective in treating metastatic prostate cancer

Primary Outcome

The frequency of response with 95% confidence limits for a binomial outcome will be calculated.

Interventions

  • DRUG prednisone
  • DRUG ixabepilone
  • DRUG mitoxantrone hydrochloride

Trial Details

FieldValue
Enrollment Target 80 participants
Start Date 2003-03
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT00058084 record still lists

NCT00058084 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 3 interventions - of which prednisone is the first listed.

NCT00058084 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00058084 about?

NCT00058084 is a clinical study titled "Ixabepilone Compared With Mitoxantrone and Prednisone in Treating Patients With Refractory Metastatic Prostate Cancer". This randomized phase II trial is studying ixabepilone to see how well it works compared to mitoxantrone and prednisone in treating patients with metastatic prostate cancer that has not responded to paclitaxel, docetaxel, or hormone therapy. Drugs used in chemotherapy work in different ways to stop ...

What is the current status of trial NCT00058084?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2003-03.

What interventions are being tested in trial NCT00058084?

The interventions under investigation include: prednisone (DRUG), ixabepilone (DRUG), mitoxantrone hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00058084?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00058084's enrollment target sits among peer trials

80 842nd of 2000 higher than 1,117 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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Source: ClinicalTrials.gov NCT00058084, the US trial registry maintained by the National Library of Medicine. NCT00058084 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.