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Recruitment Status : Withdrawn (No accrual in initial period, PI decided to close study.)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|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
- Drug: Metformin hydrochloride
Metformin is administered orally, with food. Metformin tablets contain 500mg, 850mg, or 1000mg of metformin hydrochloride. Tablets contain inactive ingredients including pofidone and magnesium stearate. The coating for 500mg and 850mg tablets contains hypromellose. Metformin is an antihyperglycemic agent which decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.In this study, Metformin will be given 850 mg orally, with food, once daily for 1 week starting the week before first docetaxel infusion, and thereafter 850 mg twice daily.
- Drug: Docetaxel
Docetaxel will be administered 75 mg/m2 as one hour infusion on day 1 every 21 days.
- Drug: Prednisone
Prednisone will be given 5mg orally twice daily which is the standard regimen with docetaxel
- 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|