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NCT00151060 · ClinicalTrials.gov registry record · Phase 2

Estramustine, Etoposide and Paclitaxel Treatment for Hormonally Responsive Adenocarcinoma of the Prostate

A Phase 2 study, sponsored by University of Michigan Rogel Cancer Center.

Completed
Registry status
Phase 2
Development phase
28
Enrollment target

NCT00151060 is a Phase 2 study that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 28 participants.

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The verdict

NCT00151060, a Phase 2 study, has completed, sponsored by University of Michigan Rogel Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
28 participants
Enrollment target

Study Summary

Hormonal therapy is the standard treatment for prostate cancer which has spread to other areas of the body. Despite the high initial response rates to hormonal therapy, the vast majority of men will develop cancer which is no longer responsive to hormone deprivation. The average time for hormonal therapy to be effective is about 18 months. Chemotherapy combinations which can treat the disease when it no longer responds to hormonal therapy have been developed, but these treatments are not curative. One of these combinations is estramustine, etoposide and paclitaxel. In men with far advanced disease, 60% will have a decrease in their PSA (Prostate Specific Antigen) or shrinkage of tumors after treatment with this chemotherapy. Despite this, these men have all developed further disease progression requiring additional treatment. One possible way to make chemotherapy more effective is to give it when the number of tumor cells is smallest, and the number of cells to be killed is at a low level. One situation in which this is true is when a man has responded to hormonal therapy any tumors are at their smallest size. This study will test whether the addition of chemotherapy at that time will prolong the time until the cancer becomes unresponsive to hormonal therapy.

Interventions

  • DRUG Paclitaxel
  • DRUG Etoposide
  • DRUG Estramustine

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 1998-12
Est. Completion 2006-06
Phase Phase 2

What the Registry Record Tells You About NCT00151060

The ClinicalTrials.gov registry entry for NCT00151060 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.

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

NCT00151060 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00151060 about?

NCT00151060 is a clinical study titled "Estramustine, Etoposide and Paclitaxel Treatment for Hormonally Responsive Adenocarcinoma of the Prostate". Hormonal therapy is the standard treatment for prostate cancer which has spread to other areas of the body. Despite the high initial response rates to hormonal therapy, the vast majority of men will develop cancer which is no longer responsive to hormone deprivation. The average time for hormonal th...

What is the current status of trial NCT00151060?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 1998-12. Estimated completion is 2006-06.

What interventions are being tested in trial NCT00151060?

The interventions under investigation include: Paclitaxel (DRUG), Etoposide (DRUG), Estramustine (DRUG).

Who is sponsoring clinical trial NCT00151060?

This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.