Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer
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ClinicalTrials.gov Identifier: NCT00038181 |
Recruitment Status
:
Completed
First Posted
: May 30, 2002
Last Update Posted
: August 1, 2012
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Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
Tracking Information | |||
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First Submitted Date ICMJE | May 29, 2002 | ||
First Posted Date ICMJE | May 30, 2002 | ||
Last Update Posted Date | August 1, 2012 | ||
Study Start Date ICMJE | October 2000 | ||
Actual Primary Completion Date | November 2005 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE | Not Provided | ||
Original Primary Outcome Measures ICMJE | Not Provided | ||
Change History | Complete list of historical versions of study NCT00038181 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE | Not Provided | ||
Original Secondary Outcome Measures ICMJE | Not Provided | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Preoperative Thalidomide Followed By Radical Retropubic Prostatectomy In Select Patients With Locally Advanced Prostate Cancer | ||
Official Title ICMJE | A Tolerance and Efficacy Trial of Preoperative Thalidomide Treatment Followed by Radical Retropubic Prostatectomy (RRP) in Select Patients With Locally Advanced Prostate Cancer | ||
Brief Summary | The goal of this clinical research study is to find out whether it is safe to treat patients diagnosed with locally advanced prostate cancer with the drug Thalidomide before removing the tumor (radical retropubic prostatectomy). Researchers also want to learn if Thalidomide can shrink or slow the growth of the prostate cancer before the surgery |
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Detailed Description |
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Study Type ICMJE | Interventional | ||
Study Phase | Phase 2 | ||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Prostate Cancer | ||
Intervention ICMJE | Drug: Thalidomide | ||
Study Arms | Not Provided | ||
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 | Completed | ||
Actual Enrollment ICMJE |
18 | ||
Original Enrollment ICMJE |
40 | ||
Actual Study Completion Date | November 2005 | ||
Actual Primary Completion Date | November 2005 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion criteria
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Sex/Gender |
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Ages | Child, 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 | NCT00038181 | ||
Other Study ID Numbers ICMJE | ID00-089 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | M.D. Anderson Cancer Center | ||
Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||
Collaborators ICMJE | Celgene Corporation | ||
Investigators ICMJE | Not Provided | ||
PRS Account | M.D. Anderson Cancer Center | ||
Verification Date | July 2012 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |