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NCT00331344 · ClinicalTrials.gov registry record · Phase 1
Treating Patients With Metastatic Prostate Cancer Not Responding to Hormone and Chemotherapy
A Phase 1 study of Recurrent Prostate Cancer and Stage IV Prostate Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 2
- Study locations
NCT00331344: Completed Phase 1 study of Recurrent Prostate Cancer and Stage IV Prostate Cancer, sponsored by National Cancer Institute (NCI).
NCT00331344 is a Phase 1 study of Recurrent Prostate Cancer and Stage IV Prostate Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 100 participants, below the 134-participant average among 21 other Recurrent Prostate Cancer trials with a reported enrollment target (25% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00331344, a Phase 1 study of Recurrent Prostate Cancer and Stage IV Prostate Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 2
- Study locations
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
Primary Outcome
Descriptive statistics will be calculated to characterize the disease and treatment factors including the proportion responding with a 95% confidence interval. If accrual is completed and more than 15 of 58 patients show \> 50% Prostate Specific Antigen (PSA) declines after 3 courses, then the null hypothesis of a 20% response proportion will be rejected. PSA declines for individual patients will be plotted in the form of a waterfall diagram of maximal PSA declines. 58 patients were enrolled fo
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 |
What the finished NCT00331344 record still lists
NCT00331344 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 134-participant average among 21 other Recurrent Prostate Cancer trials with a reported enrollment target (25% lower).
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.
NCT00331344 reports a single indexed study location in California, Wisconsin.
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.
What interventions are being tested in trial NCT00331344?
The interventions under investigation include: prednisone (DRUG), ixabepilone (DRUG), mitoxantrone hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00331344?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Recurrent Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00331344's enrollment target sits among peer trials
100 5th of 21 higher than 17 of 21 other Recurrent Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Prostate Cancer 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.
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