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NCT00134056 · ClinicalTrials.gov registry record · Phase 3

S0421, Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone Therapy

A Phase 3 study, sponsored by SWOG Cancer Research Network.

Completed
Registry status
Phase 3
Development phase
1,038
Enrollment target

NCT00134056 is a Phase 3 study that has completed, run by SWOG Cancer Research Network. The registered enrollment target is 1,038 participants.

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The verdict

NCT00134056, a Phase 3 study, has completed, sponsored by SWOG Cancer Research Network.

COMPLETED
Registry status
Phase 3
Development phase
1,038 participants
Enrollment target

Study Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, prednisone, and atrasentan 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. It is not yet known whether docetaxel, prednisone, and atrasentan are more effective than docetaxel and prednisone in treating prostate cancer. PURPOSE: This randomized phase III trial is studying docetaxel, prednisone, and atrasentan to see how well they work compared to docetaxel and prednisone in treating patients with stage IV prostate cancer and bone metastases that did not respond to previous hormone therapy.

Interventions

  • DRUG prednisone
  • OTHER placebo
  • DRUG docetaxel
  • DRUG atrasentan hydrochloride

Trial Details

FieldValue
Enrollment Target 1,038 participants
Start Date 2006-08
Est. Completion 2016-02
Phase Phase 3

Sponsor

SWOG Cancer Research Network

270 total trials

What the Registry Record Tells You About NCT00134056

The ClinicalTrials.gov registry entry for NCT00134056 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,038 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 270 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which prednisone is the first listed.

NCT00134056 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00134056 about?

NCT00134056 is a clinical study titled "S0421, Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone Therapy". RATIONALE: Drugs used in chemotherapy, such as docetaxel, prednisone, and atrasentan 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. It is not yet ...

What is the current status of trial NCT00134056?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,038 participants. The study started on 2006-08. Estimated completion is 2016-02.

What interventions are being tested in trial NCT00134056?

The interventions under investigation include: prednisone (DRUG), placebo (OTHER), docetaxel (DRUG), atrasentan hydrochloride (DRUG).

Who is sponsoring clinical trial NCT00134056?

This trial is sponsored by SWOG Cancer Research Network, which has 270 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.