Metformin With Standard Taxotere and Prednisone in the Treatment of Castration Resistant Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01478308|
Recruitment Status : Withdrawn (No accrual in initial period, PI decided to close study.)
First Posted : November 23, 2011
Last Update Posted : March 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: Metformin hydrochloride Drug: Docetaxel Drug: Prednisone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metformin With Standard Taxotere and Prednisone in the Treatment of Castration Resistant Prostate Cancer|
|Study Start Date :||June 2011|
|Primary Completion Date :||October 2011|
|Study Completion Date :||October 2011|
Drug: Metformin hydrochloride
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01478308
|Principal Investigator:||Richard Lauer, MD||University of New Mexico Cancer Center|