Preoperative Docetaxel for Localized Progressive Castration-resistant Prostate Cancer (CRPC)
|ClinicalTrials.gov Identifier: NCT00811031|
Recruitment Status : Withdrawn
First Posted : December 18, 2008
Last Update Posted : July 30, 2012
|First Submitted Date ICMJE||December 16, 2008|
|First Posted Date ICMJE||December 18, 2008|
|Last Update Posted Date||July 30, 2012|
|Study Start Date ICMJE||Not Provided|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Pre-to-post chemotherapy increase phosphorylation of platelet-derived growth factor receptor (PDGFR) [ Time Frame: PDGFR will be estimated for each patient based on blood samples taken at day 0 and at day 42 using the Bayesian survival time regression model. ]|
|Original Primary Outcome Measures ICMJE
||To learn how prostate cancer markers in blood cells are affected by treatment with Taxotere® (docetaxel) before surgery to remove the prostate gland. [ Time Frame: 3 Years ]|
|Change History||Complete list of historical versions of study NCT00811031 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE
||To measure the relationship between biomarkers in the body and the amount of time the disease remains stable. [ Time Frame: 3 Years ]|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Preoperative Docetaxel for Localized Progressive Castration-resistant Prostate Cancer (CRPC)|
|Official Title ICMJE||A Phase II Study of Pre-operative Docetaxel for Progressive Localized Castration Resistant Prostate Cancer|
The Study Drugs:
Docetaxel is designed to stop the growth of cancer cells, which may cause the cells to die. It is believed to be weakly effective at killing blood vessels in cancer cells as well.
Prednisone and docetaxel are commonly used to treat prostate cancer.
Study Drug Administration:
If you are found to be eligible to take part in this study, on Day 1 of every 21-day study "cycle", you will receive docetaxel through a needle in your vein over 1 hour.
Everyday, you will take prednisone by mouth 2 times a day (in the morning and evening). You should take prednisone with meals.
You will take dexamethasone by mouth at 12 hours and 6 hours before you receive docetaxel. This is to help reduce the risk of any allergic reaction and fluid retention. It is important that you take this drug on schedule.
On Day 1 of each cycle, the following tests and procedures will be performed:
Blood (about 2 teaspoons) will be drawn for routine tests and to test for PSA and testosterone levels.
On Day 1 of Cycle 3, blood (about 2 teaspoons) will be drawn to test for PDGFR and PDGF levels.
If you complete 2 cycles or more, you will be eligible to have surgery as part of this study.
If you are eligible, no more than 21 days after your last dose of docetaxel, you will have surgery to remove your prostate gland. You will sign a separate consent for this surgery, which will describe the procedure and its risks in detail.
Before surgery, probably at your pre-surgical visit, blood (about 2 teaspoons) will be drawn to test for PDGFR and PDGF levels.
Length of Study:
You will take the study drug for up to 4 cycles before having surgery. You will be off study treatment after you have surgery. You will be taken off study early if you experience intolerable side effects or the disease gets worse.
This is an investigational study. Docetaxel given with prednisone is commercially available and FDA approved for the treatment of prostate cancer.
Up to 28 participants will take part in this study. All will be enrolled at M. D. Anderson.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Prostate Cancer|
|Study Arms||Experimental: Taxotere + Prednisone
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE
|Study Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|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||Not Provided|
|Removed Location Countries||United States|
|NCT Number ICMJE||NCT00811031|
|Other Study ID Numbers ICMJE||2008-0045|
|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|
|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