Study of Docetaxel With Doxercalciferol or Placebo for Advanced Prostate Cancer
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ClinicalTrials.gov Identifier: NCT00582582 |
Recruitment Status
:
Terminated
(Lack of drug supply for doxercalciferol for this study)
First Posted
: December 28, 2007
Last Update Posted
: October 2, 2015
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Sponsor:
University of Wisconsin, Madison
Collaborators:
Sanofi
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
University of Wisconsin, Madison
Tracking Information | ||||
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First Submitted Date ICMJE | December 19, 2007 | |||
First Posted Date ICMJE | December 28, 2007 | |||
Last Update Posted Date | October 2, 2015 | |||
Study Start Date ICMJE | April 2002 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
Objective response rate [ Time Frame: At 12 weeks on study ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00582582 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Safety [ Time Frame: Duration of study participation through 30 days post last treatment dose ] | |||
Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study of Docetaxel With Doxercalciferol or Placebo for Advanced Prostate Cancer | |||
Official Title ICMJE | Phase II Evaluation of Docetaxel Randomized With Doxercalciferol or Placebo in Patients With Advanced Prostate Cancer | |||
Brief Summary | The purpose of this research study is to find out the toxicities of doxercalciferol given in combination with docetaxel (Taxotere®), as well as to see how well this combination works in the treatment of prostate cancer. | |||
Detailed Description | This is a multi-institutional, double-blinded, randomized study comparing docetaxel plus doxercalciferol versus docetaxel plus placebo in patients with metastatic hormone refractory prostate cancer. Docetaxel is given intravenously on days 1, 8 and 15 for every 28 day cycle and doxercalciferol or placebo is taken orally every day of the 28 day cycle. Please refer to the Eligibility Criteria below for key inclusion and exclusion criteria. | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Prostate Cancer | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
70 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | April 2007 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00582582 | |||
Other Study ID Numbers ICMJE | HSC 2001-484 CO01802 |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | University of Wisconsin, Madison | |||
Study Sponsor ICMJE | University of Wisconsin, Madison | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Wisconsin, Madison | |||
Verification Date | April 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |