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NCT00176293 · ClinicalTrials.gov registry record · Phase 2
Randomized Phase II Trial of Doxil With or Without Dexamethasone for Metastatic Hormone Refractory Prostate Cancer
A Phase 2 study, sponsored by University of Kentucky.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT00176293 is a Phase 2 study that was terminated before completion, run by University of Kentucky. The registered enrollment target is 2 participants.
The verdict
NCT00176293, a Phase 2 study, was terminated before completion, sponsored by University of Kentucky.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess disease response to Doxil in patients with hormone refractory prostate cancer with or without dexamethasone pre-treatment. Study Design: We will perform an open labeled, parallel, randomized phase II study using a two-stage design to determine if there is sufficient anti-tumor activity in either arm to warrant further study. Assumptions made in this study: an unacceptable overall response rate is \</= 10% \& we will pursue further study if the overall response rate is \>/= 30%. Fifteen patients will be randomized in the first phase (to both Arm 1 and Arm 2). No further patients will be accrued if \<2/15 responses are noted in a given arm. Ten additional patients will be enrolled if \>/= 2/15 responses are observed. If there are \>/= 5/25 responses then further studies will be pursued with that regimen. We will determine the overall incidence \& severity of toxicities in both arms. Treatment: Arm 1: Doxil: Dose: 50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Arm 2: Doxil: Dose: 50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Arm 1 only: Dexamethasone: Dose: 12 mg twice a day by mouth on days 1, 2, 3, 4, 5 of each 28 day cycle. Number of Cycles for both Arm 1 \& 2: until progression or unacceptable toxicity develops.
Interventions
- DRUG dexamethasone
- DRUG doxorubicin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2005-10 |
| Est. Completion | 2007-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00176293
The ClinicalTrials.gov registry entry for NCT00176293 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Kentucky, which has 54 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which dexamethasone is the first listed.
NCT00176293 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00176293 about?
NCT00176293 is a clinical study titled "Randomized Phase II Trial of Doxil With or Without Dexamethasone for Metastatic Hormone Refractory Prostate Cancer". The primary objective of this study is to assess disease response to Doxil in patients with hormone refractory prostate cancer with or without dexamethasone pre-treatment. Study Design: We will perform an open labeled, parallel, randomized phase II study using a two-stage design to determine if th...
What is the current status of trial NCT00176293?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2005-10. Estimated completion is 2007-02.
What interventions are being tested in trial NCT00176293?
The interventions under investigation include: dexamethasone (DRUG), doxorubicin (DRUG).
Who is sponsoring clinical trial NCT00176293?
This trial is sponsored by University of Kentucky, which has 54 total clinical trials registered on ClinicalTrials.gov.
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