Estramustine, Docetaxel and Zoledronate Treatment in Hormone-Refractory Adenocarcinoma of the Prostate
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|ClinicalTrials.gov Identifier: NCT00151073|
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : January 22, 2015
|Condition or disease||Intervention/treatment||Phase|
|Hormone-Refractory Prostate Cancer||Drug: Zoledronic acid Drug: Estramustine Drug: Docetaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Evaluation of Estramustine, Docetaxel and Zoledronate in Patients With Hormone-Refractory Adenocarcinoma of the Prostate|
|Study Start Date :||April 2002|
|Actual Primary Completion Date :||September 2005|
|Actual Study Completion Date :||September 2007|
Experimental: Zoledronate Alone
Zoledronate is given alone for the first cycle. All subsequent cycles consist of Docetaxel (70mg/m^2) given on day 2, Estramustine (280mg) given orally three times per day on days 1-3, and Zoledronate (4mg) given intravenously on day 2.
Drug: Zoledronic acid
Experimental: Docetaxel and Estramustine
Docetaxel and Estramustine are given for the first cycle of therapy. All subsequent cycles consist of Docetaxel (70mg/m^2) given on day 2, Estramustine (280mg) given orally three times per day on days 1-3, and Zoledronate (4mg) given intravenously on day 2.
Drug: Zoledronic acid
- The Percent Increase/Decrease in Bone Markers from Baseline to Cycle 2 Day 2 (Day 23) of Treatment [ Time Frame: Cycle 2 Day 2 of Treatment (Day 23 of Treatment) ]To assess and compare the effect of zoledronate and docetaxel/estramustine on markers of bone metabolism in patients with hormone-refractory prostate cancer.
- Percentage of Patients that Respond to Treatment [ Time Frame: Post 3 Cycles (63 days) ]A decrease in PSA of greater than or equal to 50%, without evidence of progression in the bones, will be considered as response to treatment.
- The Number of Toxicities Experienced by Patients [ Time Frame: 30 Days Post Treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00151073
|United States, Michigan|
|The University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||David C. Smith, MD||University of Michigan Cancer Center|