Metformin With Standard Taxotere and Prednisone in the Treatment of Castration Resistant Prostate Cancer
This study is being conducted to determine the effectiveness of standard 3 weekly treatments using docetaxel and prednisone with metformin in patients with castration-resistant metastatic prostate cancer.
It is also being conducted to determine the levels of toxicity of metformin when added to every 3 weekly docetaxel treatments in patients with endocrine resistent, metastatic prostate cancer.
|Prostate Cancer||Drug: Metformin hydrochloride Drug: Docetaxel Drug: Prednisone||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Metformin With Standard Taxotere and Prednisone in the Treatment of Castration Resistant Prostate Cancer|
- Measure efficacy [ Time Frame: 7 years ]To determine the antitumor activity of metformin in combination with docetaxel and prednisone which are considered standard of care administered to patients with hormone refractory prostate cancer.
- Measure toxicity [ Time Frame: 7 years ]To evaluate the quantitative and qualitative toxicities of metformin with this schedule, in this population
|Study Start Date:||June 2011|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Drug: Metformin hydrochloride
Please refer to this study by its ClinicalTrials.gov identifier: NCT01478308
|Principal Investigator:||Richard Lauer, MD||University of New Mexico Cancer Center|